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INDICATIONS AND USAGE -----------------------------­
CIBI¾AÀ³¯g¤Î¥Î³~
CIBINQO¬O¤@ÏúJanus¿E酶¡]JAK¡^§í¨î剂¡AÓì¥Î¤_ªv疗±w¦³难ªv©Ê¤¤«×¦Ü­««×¯S应©Ê¥Öª¢ªº¦¨¦~¤H¡C
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--------------------------DO

CIBINQO is a Janus kinase (JAK) inhibitor indicated for the treatment of
adults with refractory, moderate-to-severe atopic dermatitis whose disease is
not adequately controlled with other systemic drug products, including
biologics, or when use of those therapies is inadvisable. (1)

Limitation of Use: CIBINQO is not recommended for use in combination with
other JAK inhibitors, biologic immunomodulators, or with other
immunosuppressants.
--------------------------DO
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Event Details

A4 KOL Series: Episode 3, Dr Peter Lio
Jun 22, 2022

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Webcast link

ir.aslanpharma.com/events/event-details/a4-kol-series-episode-3-dr-peter-lio
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ASLAN PHARMACEUTICALS TO PARTICIPATE IN FIRESIDE CHAT AT JEFFERIES GLOBAL HEALTHCARE CONFERENCE
Menlo Park, California, and Singapore, May 31, 2022, ¡V ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that Dr Carl Firth, CEO, will participate in a fireside chat at the Jefferies Global Healthcare Conference. The conference will be held in-person in New York, NY, June 8 - 10, 2022.
Management will be available for virtual one-on-one meetings throughout the conference.
Fireside Chat details
Date: Wednesday, June 8, 2022
Time: 10:00am ET
Track: 9
Webcast link: Click here to listen in live or via replay
aslanpharma.com/app/uploads/2022/05/ASLAN-Pharmaceuticals-to-Participate-in-Fireside-Chat-at-Jefferies-Global-Healthcare-Conference.pdf

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·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2022/6/8 ¤U¤È 10:49:30²Ä 5371 ½g¦^À³
ASLAN PHARMACEUTICALS TO PARTICIPATE IN FIRESIDE CHAT AT JEFFERIES GLOBAL HEALTHCARE CONFERENCE
Menlo Park, California, and Singapore, May 31, 2022, ¡V ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that Dr Carl Firth, CEO, will participate in a fireside chat at the Jefferies Global Healthcare Conference. The conference will be held in-person in New York, NY, June 8 - 10, 2022.
Management will be available for virtual one-on-one meetings throughout the conference.
Fireside Chat details
Date: Wednesday, June 8, 2022
Time: 10:00am ET
Track: 9
Webcast link: Click here to listen in live or via replay
aslanpharma.com/app/uploads/2022/05/ASLAN-Pharmaceuticals-to-Participate-in-Fireside-Chat-at-Jefferies-Global-Healthcare-Conference.pdf

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¥[§QºÖ¥§亚¦{门¬¥©¬§J©M·s¥[©Y¡A2022¦~6¤ë7¤é¡]GLOBE NEWSWIRE¡^ -- ASLAN Pharmaceuticals¡]纳´µ达§J¡^¤½¥q¡]NASDAQ¡^¬O¬ü国ªº¤@®a¨î药¤½¥q¡C
©M·s¥[©Y¡A2022¦~6¤ë7¤é (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (NASDAQ: ASLN¡^¬O¤@®a¥H§K¬Ì学为­«点ªº临§É阶¬qªº¥Íª«¨î药¤½¥q¡A¥¿¦b开发§ï变±wªÌ¥Í¬¡ªº创·s疗ªk¡A
¤µ¤Ñ该¤½¥q«Å¥¬ÉO约¿«ÀN´¶ª÷´µ¤j学医学°|ªºShawn Kwatra³Õ¤h¡]§@为顾问¡^©M§ù§J¤j学医学¤¤¤ßªºMadan Kwatra³Õ¤h开®i¬ã¨s¦X§@¡A¬ã¨sIL-13Ra1亚单¦ì¦b2«¬¤¶¾Éªºª¢¯g©Ê¯e¯f¡A¯S别¬O¯SÀ³©Ê¥Öª¢¡]AD¡^¤¤ªº¿W¯S§@¥Î¡A³oÉO¨ä¥L³~径¦¨¤Àªº§@¥Î¤£¦P¡C

¸Ó¬ã¨s¦X§@将评¦ôIL-13Ra1¦b¤¤«×¦Ü­««×AD±wªÌý©¥»¤¤ªº§@¥Î¡A¦}将测试IL-13Ra1¤¶导ªº过±Ó¡Bª¢¯g©M调节³~径¦p¦ó¨ü¨ìeblasakimab对2«¬¨üÊ^ªº¿ï¾Ü©Ê¹v¦V¼v响¡AÉO¥Ø«e护²z标­ã¤¤对1«¬©M2«¬¨üÊ^ªºÆÎªxªý断§Î¦¨对¤ñ¡C这¨Ç¬ã¨s还将±´¯Áeblasakimab专门针对IL-13Ra1ªº¤U´å®Ä应¡A¦}¦³§U¤_进¤@¨B¤F¸ÑIL-4©MIL-13«H号传导ªº¥Íª«¬ÛÃö©Ê¡C¦X§@ªºªì¨B结ªG将¦b2022¦~¤U¥b¦~©ÜÅSµoªí¡C

Shawn Kwatra¡A医学³Õ¤h¡A¬O马¨½兰¦{¤Úûتº¼¯¥«约¿«ÀN´¶ª÷´µ¤j学医学°|ªº¥Ö肤¬ì°Æ±Ð±Â¡A¤]¬O约¿«ÀN´¶ª÷´µæ±Ö}¤¤¤ßªº¥D¥ô¡C¥Lªº临§É专业领°ì¥]¬A¯S应©Ê¥Öª¢¡BºC©Êæ±Ö}¯g¡B结节©Êæ±Ö}¯g©M¥Á±Ú¥Ö肤ªº¥Ö肤¯f学¡CKwatra³Õ¤h¬O180¦h¥÷¥Xª©ª«ªº§@ªÌ©Î¦XµÛªÌ¡A¦}¥B¬O¦³¦â¤HÏú¥Ö肤协会ªº¸³¨Æ会¦¨员¡C

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MENLO PARK, Calif. and SINGAPORE, June 07, 2022 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (NASDAQ: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that it has initiated a research collaboration with Dr Shawn Kwatra, as an advisor, from Johns Hopkins University School of Medicine and Dr Madan Kwatra from Duke University Medical Center to investigate the unique role of the IL-13Ra1 subunit, distinct from the role of other pathway components, in Type 2-mediated inflammatory diseases, specifically atopic dermatitis (AD).

The research collaboration will evaluate the role of IL-13Ra1 in moderate-to-severe AD patient samples and will test how IL-13Ra1-mediated allergic, inflammatory and regulatory pathways are affected by eblasakimab¡¦s selective targeting of the Type 2 receptor in contrast to a broader blockade of both the Type 1 and Type 2 receptors seen in current standards of care. The studies will also explore the downstream effects of specifically targeting IL-13Ra1 by eblasakimab and help to further the understanding of the biological relevance of IL-4 and IL-13 signaling. Initial findings from the collaboration will be disclosed for presentation during the second half of 2022.

Shawn Kwatra, MD, is an Associate Professor of Dermatology at the Johns Hopkins University School of Medicine in Baltimore, Maryland, and Director of the Johns Hopkins Itch Center. His areas of clinical expertise include atopic dermatitis, chronic pruritus, prurigo nodularis and dermatology for ethnic skin. Dr Kwatra has been an author or co-author on over 180 publications and is a member of the Board of Directors of the Skin of Color Society.

Madan Kwatra, PhD, is the Director of the Molecular Pharmacology Laboratory in the Department of Anesthesiology at Duke University Medical Center. Dr Kwatra is a receptor pharmacologist and was trained with Nobel Laureate Dr Bob Lefkowitz.

¡§This is an encouraging time in atopic dermatitis with a variety of novel therapies becoming available,¡¨ commented Dr Shawn Kwatra, Associate Professor of Dermatology at the Johns Hopkins University School of Medicine. ¡§To improve treatment options for patients, it is important to focus on obtaining a better understanding of the role of specific disease mechanisms targeted by different groups of therapies, such as the various components of the Type 1 and Type 2 receptor complexes that regulate IL-4 and IL-13 signaling. From advances in psoriasis, where numerous therapies have been developed, we have learned that targeting different subunits in common molecular pathways can have drastically different clinical effects. We are hopeful this study could potentially clarify the distinct roles of the Type 1 and Type 2 receptors and their components in driving AD pathogenesis.¡¨

Dr Ferda Cevikbas, Head Translational Sciences, ASLAN Pharmaceuticals, commented, ¡§This collaboration will help us understand the unique role of IL-13Ra1 signaling in AD, and provide a mechanistic basis for eblasakimab¡¦s differentiation versus other pathway-specific treatments. We are looking forward to working with Dr Shawn Kwatra and Dr Madan Kwatra to generate insights that inform how the differentiated targeting of IL-13-relevant pathways might benefit AD patients who are yet to find relief from this chronic disease.¡¨
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Atopic Dermatitis Market Size and Trend Report including Epidemiology and Pipeline Analysis, Competitor Assessment, Unmet Needs, Clinical Trial Strategies and Forecast, 2021-2030
Pages: 111 Published: March 31, 2022 Report Code: GDHC243PIDR
Add to Saved List
OverviewKey PlayersContentsTablesFiguresFAQ
The atopic dermatitis market size was valued at $6.4 billion in 2020. The market is expected to grow at a CAGR of more than 10% during the forecast period. Atopic dermatitis (AD) is a chronic or chronically relapsing inflammatory skin disease arising from a complex interrelationship of environmental, immunologic, genetic, and pharmacologic factors. Also known as atopic eczema, it is characterized by pruritus (an unpleasant sensation that elicits the desire to scratch), redness, scaling, and flaking of the skin surface.
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The atopic dermatitis (AD) market is expected to grow from a value of $6.4 billion in 2020 to $16.8 billion in 2030 in the seven major markets at a compound annual growth rate (CAGR) of 10.1%, according to GlobalData.
www.thepharmaletter.com/article/growth-in-atopic-dermatitis-market-to-exceed-10-at-cagr

2022/04/05




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Eblasakimab may be efficacious against a wide range of AD
comorbidities, such as asthma and allergy

Eblasakimab¥i¯à¹ï¼sªxªºAD¦X¨Ö¯g¦³Àø®Ä¡C
¡A¦p­ý³Ý©M¹L±Ó¯g¡C

p.12
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81% of moderate-to-severe AD patients have Type 2 inflammatory comorbidities:

¤¤­«¯gAD±wªÌ,±w¦³«¬2ª¢¯gªº¨Öµo¯g81%

¨ä¤¤±w¹L±Ó©Ê»óª¢ªÌ¨Öµo¯g 50%
¨ä¤¤±w¹L±ÓªÌ¨Öµo¯g 38%
¨ä¤¤±w­ý³Ý¨Öµo¯g 35%
¨ä¤¤±w­¹ª«¹L±Ó¨Öµo¯g 34%

Blockade of IL-4 and IL-13
signaling through the Type 2
receptor will be important to
address both IL-4 and IL-13
driven comorbidities in AD
patients.

Physicians would prefer
treatment options that can
address these other
conditions.

ªýÂ_ IL-4 ©M IL-13 ³q¹L«¬ 2 µo«H¸¹¨üÅé
±N«Ü­«­n¥i¦P®É¸Ñ¨MAD±wªÌ¦] IL-4 ©M IL-13ÅX°Êªº¦X¨Ö¯g
¡C

Âå¥Í­Ì§ó³ßÅw¥i¦P®ÉªvÀø¨ä¥L¦X¨Ö¯gªºÃÄ¡C

¸ê®Æ¨Ó·½: 237¦ì±wªÌªº¬ã¨s.µoªí©ó2022¦~AAD ¦~·|.
Source: Calzavara-Pinton et al (2022) AAD Annual Meeting poster presentation, Baseline patient demographics and comorbidities in patients with atopic dermatitis from the GLOBOSTAD registry (237 patients)
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-----------------------------------------------
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-------------------
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¤]¸ÑÄÀ Lebrikizumab ¤G´ÁÁ{§É¹w«á¥D­n«ü¼Ð»P¹ï·Ó²Õ¤ñ ­È ¥u¦³Dupilumab 50%~75%
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www.marketbeat.com/stocks/NASDAQ/AS
LN/price-target/

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3.7/9/2021 Jefferies Financial Group 8¬ü¤¸/ªÑ
4.12/2/2019 Piper Jaffray Companies 8¬ü¤¸/ªÑ


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www.ncbi.nlm.nih.gov/pmc/articles/PMC7142380/

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----------------------------------------
·|­û¡G¤Ñ©R10141925 µoªí®É¶¡:2022/5/15 ¤U¤È 07:17:40²Ä 5310 ½g¦^À³
Dupilumab 2­Ó¤T´ÁÁ{§É,°ò½u¶}©l«e35¤Ñ¶¡ªº¤H¿ï¿z¿ï¥h°£²v36.3%

1.SOLO1 ,Out of 917 participants, 671 were randomized (¿z¿ï¥h°£±¼917-671=246¤H, ¥h°£²v36.6%)
2.SOLO2, Out of 962 participants, 708 were randomized (¿z¿ï¥h°£±¼962-708=254¤H, ¥h°£²v35.8%)
¤p­p 1879 ¤H°Ñ¥[¿z¿ï ,1379¤H¶i¤J¤T´ÁÅç§ÉªºÀH¾÷¤À°t,
¥h°£²v: (1879-1379)/1379=36.3%



Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (SOLO 1)
clinicaltrials.gov/ct2/show/results/NCT02277743

Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (SOLO 2)
clinicaltrials.gov/ct2/show/results/NCT02277769


SOLO1

Out of 917 participants, 671 were randomized and 669 were treated in the study.

Participants were randomized in 1:1:1 ratio to receive Dupilumab 300 mg once weekly (qw), Dupilumab 300 mg every 2 weeks (q2w) or Placebo qw

SOLO2

Recruitment Details The study was conducted in 10 countries between 03 December 2014 and 21 January 2016. A total of 962 participants were screened in the study.
Pre-assignment Details Out of 962 participants, 708 were randomized and 707 were treated in the study. Participants were randomized in 1:1:1 ratio to receive Dupilumab 300 mg once weekly (qw), Dupilumab 300 mg every 2 weeks (q2w) or Placebo qw.
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¤@¡BLebrikizumab(16¶g),¤T´Áªº¨â­ÓÁ{§É

In ADvocate 1,

(IGA) 43%-13%=30%
EASI 59%-16%=43%

In ADvocate 2,

(IGA) 33%-11%=22%
EASI75 51%-18%=33%

¤G¡BASLAN004 (8¶g)1b¡A¡K¡K¼ÒÀÀ2b¡A16¶g

EASI75 69%-15%(¹ï·Ó²Õ)=54%
(IGA) 53%-12%(¹ï·Ó组)=41%

¤T¡BASLAN004 2b vs Lebrikizumab

1. ASLAN004 Vs ADvocat1
EASI75 54% VS 43%, (54%/43%=126%)
(IGA) 41% VS 30%, (41%/30%=137%)

2.ASLAN004 VS ADvocat2
EASI75 54% VS 33%,(54%/33%=164%)
(IGA) 41% VS 22%,(41%/22%=186%)

¥|¡Aµ²½×¡ALebrekizumab MOA³y¦¨¹ïIL4ªº资°T¶Ç»¼¡A®É¦³®ÉµL¡C³y¦¨2­ÓAD¤T´ÁÀø®Ä®É¦n®É®tª¬ºA¡C


¦b­ý³Ý¤T´Áªº2­ÓÁ{§É¤]§e²{¡A¥D­n«ü¼Ð¤@­ÓP­È<0.05¡A¥t¤@­Ó>0.05ªºª¬ºA¡A¦Ó¤¤¤î¬ã¨s¡C

¤­¡B¨Ì¾ÚLebrekizumab ³Q§ª«¨Ó¨ÖÁÊ»ù11»õ¬ü¤¸¡C

¥¼¨Ó¨ÖÁʵo¥Í,¥i¯à¦X¬ù: ¦ô­p¤Î±ø¥ó



11/50*145*2=64»õ¬ü¤¸(¨È·à¿W±o)

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*2 ­¿(¨ä¥L004¾AÀ³¯g­ý³Ý/COPD/EOE...¤ÎASLAN003»ù­È.)

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¤@.Lebrikizumab(16¶g)¤T´Á

In ADvocate 1,

(IGA) 43%-13%=30%
EASI75 59%-16%=43%

¤G¡BASLAN004 (8¶g)1b¡A¡K¡K¼ÒÀÀ2b¡A16¶g

EASI75 69%-15%(¹ï·Ó²Õ)=54%
(IGA) 53%-12%(¹ï·Ó组)=41%

¤T¡BASLAN004 2b vs Dupilumab ¤T´Á
¦©°£¹ï·Ó组«áªºPK
EASI75 54% vs 36%(54%/36%=150%)
(IGA) 41% vs 28% (41%/28%=146%)

ASLAN004 ±N¤j´TÀu©óDupilumabªºÁͶաC

¥H¤W­Ó¤H¼ÒÀÀ

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¨ÌASLAN004 ¯à¦P®Éªý断IL4/IL13 ªºMOA¡A²z½×¤WÀø®Ä
赢¹LLebrikizumab ¤T´Áªºªí²{¡C

2b ¤½¥qµ´¹ï·|¦b¶i¤JÁ{§É«e­ç°£«D¶Ç²ÎAD(§CTRAC/§CIgE/§CEASI/µL¨Öµo¯g)

Àu©ó¤½¥q²³ø¤¤ªº±Ó·P«×¤ÀªRÀø®Ä¾÷·|°ª¡C


¡G¤Ñ©R10141925 µoªí®É¶¡:2022/4/4 ¤U¤È 10:20:46²Ä 169 ½g¦^À³
­Ó¤H¬Ýªk

Lebrikizumab(16¶g) VS Dupilumab(¤T´Á ¼Æ¾Ú¦©°£¹ï·Ó²Õ )

¦n®ø®§¬O§@¥Î¦bIL13 Lebrikizumab ¤T´Á(16¶g) ¥X²{¤@¥b¾÷·|¥i¯àÀu©óDupilumab ¤T´Á.


Lebrikizumab MOA :
±µ¦X IL13 ªºB¡BCÁ³±Û ,
IL13 & IL-13R£\1 ¤´¥i±µ¦X¡A¥u¬OµLªk¦A±µ¦X IL-4 R£\, ¥iªý¤îIL13°T¸¹¶Ç»¼.

¦ýLebrikizumab , IL13 & IL-13R£\1 ±µ¦X¦û¾Ú ³¡¥÷IL-13R £\1, ¼vÅT³¡¥÷ IL4 °T¸¹¶Ç»¼¡C
IL-13R £\1¥¼³Q¦û¾ÚªÌ,IL4°T¸¹¯à³Q¶Ç»¼¨ìTYPE II recepter ,¦Ó¨Ï¡«á°ªÀø®ÄÅÜ®t.

------------------------
ASLAN004 MOA ±µ¦X IL-13R£\1 ,¥i±æ¦³¾÷·|§óí©wªºÂ¡«á°ªÀø®Ä,
Àu©óLebrikizumab(16¶g)In ADvocate 1 ¾÷·|°ª.

------------------------------------------


¤@.Lebrikizumab(16¶g)

In ADvocate 1,

(IGA) 43%-13%=30%
EASI 59%-16%-43%

In ADvocate 2,

(IGA) 33%-11%=22%
EASI75 51%-18%=33%

¤G.Dupilumab ¤T´Á(16¶g)
In SOLO 1,

(IGA) 38%-10%=28%
EASI75 51%-15%=36%

In SOLO2 2,

(IGA) 36%-8%=28%
EASI75 44%-12%=32%


----------------------------------


Lebrikizumab ¤G­Ó¤T´Á¥D­n«ü¼Ð16¶g¡«áÀø®Ä¡C¤@¤@¤@¤@2022AAD¦~·|¤fÀY³ø§i


In ADvocate 1,
43 percent of patients receiving lebrikizumab achieved clear or almost clear skin (IGA) at 16 weeks compared to 13 percent of patients taking placebo.
Among those receiving lebrikizumab, 59 percent achieved an EASI-75 response, compared to 16 percent with placebo.


In ADvocate 2,
33 percent of patients taking lebrikizumab achieved clear or almost clear skin (IGA) at 16 weeks, compared to 11 percent of patients on placebo.
Among those receiving lebrikizumab, 51 percent achieved an EASI-75 response, compared to 18 percent taking placebo.


www.nejm.org/doi/full/10.1056/nejmoa1610020
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Mean change in peak P-NRS from baseline
600mgX8¶g¡C
Percentage change from baseline in the Pruritus Numerical Rating Scale (NRS) score weekly up to Week 8.

¹êÅç²Õ 37% VS 16% P=0.032

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»P¹ï·Ó±ø¥ó¬Û¤ñ¡AEblasakimab ÅãµÛ­°§C¤F²Ó­M¦]¤l¼W±jªº¯«¸g¤¸¹ï IL-4 ©M IL-13 ÅX°Êªºæ±Äoªº¤ÏÀ³¶W¹L 40% (p=0.0001)2¡A³oªí©ú eblasakimab ªýÂ_ IL-13R£\1 ªº¿W¯S¾÷¨î¥i¥H´£¨Ñ¤À¤l°ò¦¦b 1b ´ÁÁ{§É¸ÕÅ礤¡A¦b eblasakimab ªvÀøªº¤¤«×¦Ü­««× AD ±wªÌ¤¤Æ[¹î¨ìªºæ±Äoµû¤ÀÅãµÛ­°§C¡C

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¥[§QºÖ¥§¨È¦{ªù¬¥©¬§J©M·s¥[©Y¡A2022 ¦~ 5 ¤ë 20 ¤é (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (Nasdaq: ASLN) ¬O¤@®aÁ{§É¶¥¬q¡B¥H§K¬Ì¾Ç¬°­«ÂIªº¥Íª«»sÃĤ½¥q¡A¶}µo³Ð·sÀøªk¥H§ïÅܱwªÌªº¥Í¬¡¡A¤µ¤Ñ«Å¥¬¤FºtÁ¿¦b¥Ö½§¯f¾Ç¬ã¨s¨ó·| (SID) ¦~·|¤W¡A³q¹L eblasakimab ¹v¦V IL-13R£\1 ¬ð¥XÅã¥Ü»P¯«¸g¤¸æ±Äo¾÷¨î¬ÛÃöªº·s¼Æ¾Ú©M¨£¸Ñªº®ü³ø¡C³o¨Ç¼Æ¾Ú¥Ñ ASLAN Âà¤Æ¬ì¾Ç­t³d¤H Ferda Cevikbas ³Õ¤h´£¨Ñ¡C

ºC©Êæ±Äo¬O¯SÀ³©Ê¥Öª¢©M¨ä¥L tType 2 ÅX°Êªºª¢¯g©Ê¥Ö½§¯fªº¼Ð»x©M¥D­n¯gª¬¡C³Ìªñ±À´ú¡A¯SÀ³©Ê¥Öª¢ (AD) ¤¤ªºæ±Äo«H¸¹·|¦]¥Ö½§¤¤¦s¦bªº«Pª¢²Ó­M¦]¤l¦Ó¥[¼@ 1¡A±q¦Ó¾É­P§K¬Ì¤ÏÀ³¯}Ãa¥Ö½§«Ì»Ù¨ÃÅX°Ê¯e¯f¯f²z¡C¦b§Ú­Ìªº¬ã¨s¤¤¡A§Ú­Ìªí©ú IL-13 ©M IL-4 §@¬°¯«¸g¤¸¼W±j¾¯¡A³q¹L 2 «¬¨üÅ骺 IL-13R£\1 ¨È°ò©ñ¤jæ±Äo³~®|¡A¨Ã¥B³o¨Ç§@¥Î¥i¥H³Q¨Ì¥¬©Ô³ß³æ§Ü§í¨î¡C

ASLAN Pharmaceuticals ­º®uÂåÀø©x Alexandre Khaoukhov ³Õ¤hµû½×»¡¡G¡§°£¤F¦b¯SÀ³©Ê¥Öª¢±wªÌ¤¤¬Ý¨ìªº¯kµh¡Bµoª¢ªº¥Ö½§·l¶Ë¥~¡AºC©Êæ±Äo¥i¯à·|¥[­«³oºØ¯e¯fªº¾ãÅé­t¾á¡AÄY­«¼vÅT¥Í¬¡½è¶q¡C³o¨Ç¼Æ¾Ú´yø¤F eblasakimab ¦b´î¤Öæ±Äo©Ê¯«¸g¤¸¤ÏÀ³¤¤ªº§@¥Îªº¥O¤H¹ª»Rªºµe­±¡A¨Ã¼W¥[¤F§Ú­Ì¹ï eblasakimab ¿W¯S§@¥Î¾÷¨îªº¯q³Bªº²z¸Ñ¡A§Y³q¹L 2 «¬¨üÅéÂù­«ªýÂ_ IL-4 ©M IL-13¡C¡¨

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»P¹ï·Ó±ø¥ó¬Û¤ñ¡AEblasakimab ÅãµÛ­°§C¤F²Ó­M¦]¤l¼W±jªº¯«¸g¤¸¹ï IL-4 ©M IL-13 ÅX°Êªºæ±Äoªº¤ÏÀ³¶W¹L 40% (p=0.0001)2¡A³oªí©ú eblasakimab ªýÂ_ IL-13R£\1 ªº¿W¯S¾÷¨î¥i¥H´£¨Ñ¤À¤l°ò¦¦b 1b ´ÁÁ{§É¸ÕÅ礤¡A¦b eblasakimab ªvÀøªº¤¤«×¦Ü­««× AD ±wªÌ¤¤Æ[¹î¨ìªºæ±Äoµû¤ÀÅãµÛ­°§C¡C

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Eblasakimab ¬O¤@ºØ¼ç¦bªº¤@¬yªº¹v¦V IL-13 ¨üÅ骺³æ§J¶©§ÜÅé¡A¦³¥i¯à¬°±wªÌ´£¨Ñ®t²§¤Æªº¦w¥þ©Ê©M¦³®Ä©Ê¥H¤Î§ï¶iªºµ¹ÃĤè®×¡C 2021 ¦~ 9 ¤ë¡AASLAN «Å¥¬¤F 1b ´Á¦h¦¸»¼¼W¾¯¶q¬ã¨sªº¿n·¥µ²ªG¡A¸Ó¬ã¨s½T¥ß¤F ASLAN004 ªº·§©ÀÃÒ©ú¡A¨Ã¤ä«ù¨ä§@¬° AD ·sÀøªkªº¼ç¤O¡C 2022 ¦~ 1 ¤ë¡A¨È·à±d±Ò°Ê TREK-AD 2b ´Á¸ÕÅç¡A¥Hµû¦ô eblasakimab ¦b¤¤«×¦Ü­««× AD ±wªÌ¤¤ªº¦w¥þ©Ê©M¦³®Ä©Ê¡C
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ASLAN Pharmaceuticals Presents Late-Breaking Poster on Eblasakimab and Neuronal Itch Mechanisms at the 2022 Society for Investigative Dermatology Annual Meeting

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¥D题¬° New insights into neuronal itch mechanisms by targeting IL-13R£\1 with eblasakimab ªº®ü报®i¥Ü¤F¤HÃþ­I®Ú¯«¸g¸`¡]hDRG¡^¯«¸g¤¸¸geblasakimab¡B单独IL-4¡B单独IL-13©ÎIL-4©MIL-13组¦X预³B²z«áªºÅé¥~¬ã¨s结ªG¡C³q¹L¬¡细­M¶t质¦¨¹³®·®»¯«经¤¸ªº¤Ï应¡C

Eblasakimab©ú显ú£¤Ö¤F细­M¦]¤l¼WüLªº¯«¸g¤¸¹ïIL-4©MIL-13驱动ªºæ±Ö}¤ÏÀ³¡A»P¹ï·Ó²Õ¬Û¤ñú£¤Ö¤F40%¥H¤W¡]p=0.0001¡^2¡A这ªí©úEblasakimabªý断IL-13R£\1ªº¿W¯S¾÷¨î¥i¥H¬°1b´ÁÁ{§É试验¤¤观¹î¨ìªºEblasakimabªv疗ªº¤¤­««×AD±wªÌæ±Ö}评¤Àªº©ú显ú£¤Ö´£¨Ñ¤À¤l°ò础¡C

Publication details
The poster titled, ¡§New insights into neuronal itch mechanisms by targeting IL-13R£\1 with eblasakimab¡¨ presents results from an ex vivo study in human dorsal root ganglia (hDRG) neurons after being pre-treated with eblasakimab, IL-4 alone, IL-13 alone or a combination of both IL-4 and IL-13. Neuronal responses were captured by live cell calcium imaging.

Eblasakimab significantly reduced cytokine-enhanced neuronal responses to IL-4 and IL-13-driven itch by more than 40% versus control conditions (p=0.0001)2, suggesting eblasakimab¡¦s unique mechanism of blocking IL-13R£\1 could provide a molecular basis for the significant reduction of pruritis scores observed in eblasakimab-treated moderate-to-severe AD patients in the Phase 1b clinical trial.

finance.yahoo.com/news/aslan-pharmaceuticals-presents-breaking-poster-110000795.html

MENLO PARK, Calif. and SINGAPORE, May 20, 2022 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced the presentation of a poster highlighting new data and insights related to neuronal itch mechanisms through eblasakimab¡¦s targeting of IL-13R£\1 at the Society for Investigative Dermatology (SID) Annual Meeting. The data were presented by Ferda Cevikbas PhD, Head of Translational Sciences at ASLAN.

Chronic itch is a hallmark and major symptom of atopic dermatitis and other tType 2-driven inflammatory skin disorders. Itch signaling in atopic dermatitis (AD) has been recently postulated to be exacerbated by pro-inflammatory cytokines present in the skin1, causing an immune response that disrupts the skin barrier and drives disease pathology. In our study, we show that IL-13 and IL-4 act as neuronal enhancers for the amplification of itch pathways through the IL-13R£\1 subunit of the Type-2 receptor and these effects can be inhibited by eblasakimab.

Dr Alexandre Khaoukhov, Chief Medical Officer, ASLAN Pharmaceuticals, commented: ¡§Aside from the painful, inflamed skin lesions seen in patients with atopic dermatitis, chronic itch can be a debilitating addition to the overall burden of this disease, significantly impairing quality of life. These data paint an encouraging picture of eblasakimab¡¦s role in reducing pruritic neuronal responses and add to our understanding of the benefits of eblasakimab¡¦s unique mechanism of action in its dual blockade of both IL-4 and IL-13 through the Type 2 receptor.¡¨

ASLAN¨î药¤½¥q­º®u医疗©xAlexandre Khaoukhov³Õ¤h评论说¡C

°£¤F¦b¯S应©Ê¥Öª¢±wªÌ¨­¤W¬Ý¨ìªºµh­W¡B发ª¢ªº¥Ö损¥~¡AºC©Êæ±Ö}¤]会¨Ï这Ïú¯e¯fªº¾ãÊ^负ü®变±o虚®z¡A严­«损®`¥Í¬¡质¶q¡C这¨Ç数Õu´y绘¤Feblasakimab¦bú£¤Öæ±Ö}©Ê¯«经¤¸¤Ï应¤è­±ªº¥O¤H¹ª»Rªº画­±¡A¦}¼W¥[¤F§Ú们对eblasakimab³q过2«¬¨üÊ^对IL-4©MIL-13进¦æ双­«ªý断ªº独¯S§@¥ÎÉó¨îªº²z¸Ñ¡C
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Eblasakimab may be efficacious against a wide range of AD
comorbidities, such as asthma and allergy

Eblasakimab¥i¯à¹ï¼sªxªºAD¦X¨Ö¯g¦³Àø®Ä¡C
¡A¦p­ý³Ý©M¹L±Ó¯g¡C

p.12
ir.aslanpharma.com/static-files/20941066-3bc3-418b-a970-9951565de0f2



81% of moderate-to-severe AD patients have Type 2 inflammatory comorbidities:

¤¤­«¯gAD±wªÌ,±w¦³«¬2ª¢¯gªº¨Öµo¯g81%

¨ä¤¤±w¹L±Ó©Ê»óª¢ªÌ¨Öµo¯g 50%
¨ä¤¤±w¹L±ÓªÌ¨Öµo¯g 38%
¨ä¤¤±w­ý³Ý¨Öµo¯g 35%
¨ä¤¤±w­¹ª«¹L±Ó¨Öµo¯g 34%

Blockade of IL-4 and IL-13
signaling through the Type 2
receptor will be important to
address both IL-4 and IL-13
driven comorbidities in AD
patients.

Physicians would prefer
treatment options that can
address these other
conditions.

ªýÂ_ IL-4 ©M IL-13 ³q¹L«¬ 2 µo«H¸¹¨üÅé
±N«Ü­«­n¥i¦P®É¸Ñ¨MAD±wªÌ¦] IL-4 ©M IL-13ÅX°Êªº¦X¨Ö¯g
¡C

Âå¥Í­Ì§ó³ßÅw¥i¦P®ÉªvÀø¨ä¥L¦X¨Ö¯gªºÃÄ¡C

¸ê®Æ¨Ó·½: 237¦ì±wªÌªº¬ã¨s.µoªí©ó2022¦~AAD ¦~·|.
Source: Calzavara-Pinton et al (2022) AAD Annual Meeting poster presentation, Baseline patient demographics and comorbidities in patients with atopic dermatitis from the GLOBOSTAD registry (237 patients)
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Dupilumab 2­Ó¤T´ÁÁ{§É,°ò½u¶}©l«e35¤Ñ¶¡ªº¤H¿ï¿z¿ï¥h°£²v36.3%

1.SOLO1 ,Out of 917 participants, 671 were randomized (¿z¿ï¥h°£±¼917-671=246¤H, ¥h°£²v36.6%)
2.SOLO2, Out of 962 participants, 708 were randomized (¿z¿ï¥h°£±¼962-708=254¤H, ¥h°£²v35.8%)
¤p­p 1879 ¤H°Ñ¥[¿z¿ï ,1379¤H¶i¤J¤T´ÁÅç§ÉªºÀH¾÷¤À°t, ¥h°£²v(1879-1379)/1379=36.3%



Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (SOLO 1)
clinicaltrials.gov/ct2/show/results/NCT02277743

Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (SOLO 2)
clinicaltrials.gov/ct2/show/results/NCT02277769


SOLO1

Out of 917 participants, 671 were randomized and 669 were treated in the study.

Participants were randomized in 1:1:1 ratio to receive Dupilumab 300 mg once weekly (qw), Dupilumab 300 mg every 2 weeks (q2w) or Placebo qw

SOLO2

Recruitment Details The study was conducted in 10 countries between 03 December 2014 and 21 January 2016. A total of 962 participants were screened in the study.
Pre-assignment Details Out of 962 participants, 708 were randomized and 707 were treated in the study. Participants were randomized in 1:1:1 ratio to receive Dupilumab 300 mg once weekly (qw), Dupilumab 300 mg every 2 weeks (q2w) or Placebo qw.
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dupilumab ¤T´Á­p¹º

p.33~34
¥Î35¤Ñªºªº®É¶¡¿z¿ï±wªÌ,°µ¤U¦C¨Æ³»¶µ

Screening/Baseline:
Informed Consent X
ICF for optional assessments2 X
Inclusion/Exclusion X X
Medical History/ Demographics X
Randomization X
Training on IVRS3 X

Efficacy:
7,8
Pruritus NRS (daily)3 X X X X X X X X X X X X X X
Pruritus Categorical Scale (daily)3 X X X X X X X X X X X X X X
POEM, DLQI, EQ-5D, HADS9 X X X X X X X X
Patient Global Assess of Disease X X X X X X X
Patient Global Assess of Treatment X X X X X
IGA, EASI, GISS, SCORAD, BSA X X X X X X X X
ACQ-5, SNOT-229 X

Safety:7
Weight X X
Height X
Vital Signs X X X X X X X X
Physical Examination X
Electrocardiogram X
Adverse Events

Laboratory Testing:(¹êÅç«Ç¸ÕÅç)
HIV ab, HBsAg, Hep C Ab, TB11
Hematology, Chemistry
Urinalysis
Pregnancy Test (WOCBP only) Serum Urine Urine Urine Urine
TARC
Total serum IgE
Antigen-specific IgE sample12
hs-CRP, ANA, anti-dsDNA, antiTPO
Skin microbiome samples (select
sites)13

Research samples(serum/plasma)


www.nejm.org/doi/suppl/10.1056/NEJMoa1610020/suppl_file/nejmoa1610020_protocol.pdf
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Dupilumab ¤T´ÁÁ{§É

1¡A¤¤Â_²v<7%
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ASLAN PHARMACEUTICALS ANNOUNCES ACCEPTANCE OF LATE-BREAKING ABSTRACT ON
EBLASAKIMAB AND NEURONAL ITCH MECHANISMS FOR POSTER PRESENTATION AT THE
2022 SOCIETY FOR INVESTIGATIVE DERMATOLOGY ANNUAL MEETING
Menlo Park, California, and Singapore, May 10, 2022 ¡V ASLAN Pharmaceuticals (NASDAQ: ASLN), a clinical-stage,immunology-focused biopharmaceutical company developing innovative treatments to transform the lives ofpatients, today announced that an abstract highlighting new data and insights related to neuronal itch mechanismsthrough eblasakimab¡¦s targeting of IL-13R£\1 has been accepted for late-breaking poster presentation at the Society for Investigative Dermatology (SID) Annual Meeting, to be held in-person from May 18 to 21, 2022, in Portland,
Oregon.Ferda Cevikbas PhD, Head of Translational Sciences at ASLAN, will present findings from an ex vivo study in humandorsal root ganglia neurons which showed a significant inhibitory effect of eblsakimab on the IL-4 and IL-13
enhanced sensitization of neuronal itch responses. IL-4 and IL-13 are central to the pathogenesis of atopicdermatitis, exacerbate inflammation and exert neuronal enhancer function to itch. Targeting the IL-13R£\1 blocks IL-4 and IL-13 signaling through the Type 2 receptor and could provide a differentiated approach to disrupt the inflammation and heightened itch experienced by AD patients.
2022 Society for Investigative Dermatology Annual Meeting poster details
Title: New insights into neuronal itch mechanisms by targeting IL-13R£\1 with eblasakimab
Presentation date and time: Poster Session 1, Thursday, May 19, 2022, 4:30 - 6:30PM ET
Presenter: Dr Ferda Cevikbas, Head Translational Sciences, ASLAN Pharmaceuticals
Location: Oregon Convention Centre, Exhibit Hall A/A1/B
Abstract number: LB1039
The poster will be available to view online in the Investor Relations section of ASLAN¡¦s website following
presentation: ir.aslanpharma.com/.



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¦ôASLAN004 IGA0,1 ¬ù= EASI 75 - 13%~15%

Dupilumab ¤T´Á, ¦©°£¹ï·Ó²Õ«áIGA0,1=28%
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Humira®ªº¥Íª«¥é»sÃı¡ªp·§­z

¬ü°êªº¥Íª«¥é»sÃÄ¥«³õ¦b2023¦~±N¬O«D±`¿E°Ê¤H¤ßªº¤@¦~¡A³o¥D­n¬O¥Ñ©ó¥i¯à·|¦³10¦h­Ó¥Íª«¥é»sÃÄÄvª§ªÌ°w¹ï¥@¬É¤W¦³¥v¥H¨Ó³ÌºZ¾PªºÃĪ«Humira®¡]ªü¹F¤ì³æ§Ü¡^1±À¥X¡C¦Û2003¦~­º¦¸¦b¬ü°ê¤W¥«¥H¨Ó¡AHumira®§@¬°¤@ºØ²£«~¤w¸g¦b³\¦h¤è­±µo¥Í¤FÅܤơA¥]¬A·sªº¿@«×¡BµLÂfÂc»ÄÆQª©¥»¡BµL¨Å½¦µ¹Ãĸ˸m©M§ó¤pªº°wÀY¤Ø¤o¡CŲ©ó¹L¥h18¦~¤¤¥X²{ªº²³¦h²£«~ÄݩʡA¤F¸Ñ±q²£«~®t²§¤Æªº¨¤«×¹w´Á¤°»ò¬O¤@¶µ¨ã¦³¬D¾Ô©Êªº¥ô°È¡C

www.cardinalhealth.com/en/product-solutions/pharmaceutical-products/biosimilars/humira-biosimilar-landscape-overview.html

FDA approved (FDA ¤w®Ö·Ç7ºØHurmira ¥Íª«¬Û¦üÃÄ)

Product Company Estimated launch Concentration Seeking interchangeability Citrate free Latex free Needle size
Amjevita™ Amgen Jan 31, 2023 Low (50MG) No2 Yes No 29G Syr. / 27G Pen
Hadlima™ Organon July 1, 2023 Low (50MG) No3 No Yes 29G Syr. / 29G Pen
Cyltezo® Boehringer Ingelheim July 1, 2023 Low (50MG) Yes
(Oct 18, 2021)4 Yes No 27G Syr. / 27G Pen
Yusimry™ Coherus July 1, 2023 Low (50MG) No Yes Yes Unknown
Hulio™ Viatris July 31, 2023 Low (50MG) No Yes Yes 29G Syr. / 29G Pen
Hyrimoz™ Sandoz Sept 30, 2023 Low (50MG) No No No 27G Syr. / 27G Pen
Abrilada™ Pfizer Nov 20, 2023 Low (50MG) Yes5 Yes Yes 29G Syr. / 29G Pen


Pending approval («Ý®Ö·Ç5ºØHurmira ¥Íª«¬Û¦üÃÄ)
Product Company Estimated launch Concentration Seeking interchangeability Citrate free Latex free Needle size
SB5-HC Organon July 1, 2023 High (100MG) Yes6 Yes Yes 29G Syr. / 29G Pen
Idacio® Fresenius Kabi Sept 30, 2023 Low (50MG) No7 Yes Yes 29G Syr. / 29G Pen
AVT-02 Teva July 1, 20238 High (100MG) Yes Yes Yes Unknown
CT ¡V P17 Celltrion TBD High (100MG) No Yes Yes 29G Syr. / 29G Pen
ABP ¡V 501 HC Amgen TBD High (100MG) Yes2 Yes No 29G Syr. / 27G Pen
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Humira ªº²Ä¤@­Ó¥Íª«¬Û¦üÃÄ ¦w¶i¤½¥qªº2016¦~AMJEVITA (adalimumab-atto)FDA®Ö·Ç ,2023¦~¤~¯à¦b¬ü°ê¤W¥«.

¦³7ºØ¾AÀ³¯g,¦U¤T´ÁÁ{§Éµ²ªG¸ê®Æ¦p¤U: ¼ÐÅÒÀÉ
AMJEVITA (adalimumab-atto) injection for subcutaneous use.
Initial U.S. Approval: 2016
AMJEVITA (adalimumab-atto) is biosimilar* to HUMIRA (adalimumab).

www.accessdata.fda.gov/drugsatfda_docs/label/2016/761024lbl.pdf
Ãþ­·Àã©ÊÃö¸`ª¢¡]RA¡^¡]1.1¡^¡C´î¤ÖÅé¼x©M¯gª¬¡C
»¤µo¥D­nªºÁ{§É¤ÏÀ³¡A§í¨îµ²ºc©Ê·l®`ªºµo®i¡A§ïµ½¦¨¦~RA±wªÌªº¨­Åé¥\¯à¡C
·l¶Ë¡A¨Ã§ïµ½¦¨¦~RA±wªÌªº¨­Åé¥\¯à¡C
¤¤«×¦Ü­««×¬¡°Ê©ÊRA±wªÌ¡C
- «C¤Ö¦~¯Sµo©ÊÃö¸`ª¢¡]JIA¡^¡]1.2¡^¡C´î¤Ö¤¤«×¦Ü­««×¬¡°Ê©ÊRAªº¯gª¬©MÅé¼x¡C
4·³¤Î¥H¤W±wªÌªº¤¤«×¦Ü­««×¬¡°Ê©Ê¦hÃö¸`ª¢ªº¯gª¬¡C
4·³¤Î¥H¤W¡C
- »È®h¯fÃö¸`ª¢¡]PsA¡^¡]1.3¡^¡C´î¤ÖÅé¼x©M¯gª¬¡C
§í¨îµ²ºc©Ê·l®`ªºµo®i¡A¨Ã§ïµ½¬¡°Ê©Ê»È®h¯f±wªÌªº¨­Åé¥\¯à¡C
¬¡°Ê©Ê»È®h¯f¦¨¦~±wªÌªº¥\¯à¡C
- ±jª½©Ê¯á¬Wª¢¡]AS¡^¡]1.4¡^¡C´î¤Ö¬¡°Ê©Ê±jª½©Ê¯á¬Wª¢¦¨¦~±wªÌªºÅé¼x©M¯gª¬¡C
¬¡°Ê©Ê±jª½©Ê¯á¬Wª¢ªº¦¨¦~±wªÌªºÅé¼x©M¯gª¬¡C
- ¦¨¤H§Jù®¦¯f¡]CD¡^¡]1.5¡^¡C´î¤ÖÅé¼x©M¯gª¬¨Ã»¤¾É©Mºû«ùÁ{§É½w¸Ñ
»¤¾É¨Ãºû«ù¦¨¤H§Jù®¦¯f±wªÌªºÁ{§É½w¸Ñ¡C
¤¤«×¦Ü­««×¬¡°Ê©Ê§Jù®¦¯f±wªÌ¡A¹ï±`³WªvÀø¤ÏÀ³¤£¥R¤À¡A´î¤Ö¯gª¬©M»¤¾É¨Ãºû«ùÁ{§É½w¸Ñ¡C
¹ï±`³WªvÀø¤ÏÀ³¤£¨¬ªº¤¤«×¦Ü­««×¬¡°Ê©Ê§Jù®¦¯f¦¨¤H±wªÌ¡A´î¤Ö¯gª¬©M»¤¾É¨Ãºû«ùÁ{§É½w¸Ñ¡C´î¤ÖÅé¼x©M
´î¤Ö³o¨Ç±wªÌªºÅé¼x©M¯gª¬¡A¨Ã»¤¾É¨äÁ{§É½w¸Ñ¡A¦pªG¥L­Ì¹ï¶Ç²ÎÀøªk¥¢¥h¤ÏÀ³©Î¤£­@¨üªº¸Ü¡C
¹ï­^¤Ò§Q¦è³æ§Ü¥¢¥h¤ÏÀ³©Î¤£­@¨ü¡C
- ¼ìºÅ©Êµ²¸zª¢¡]UC¡^¡]1.6¡^¡C»¤¾É©Mºû«ùÁ{§É½w¸Ñ
¤¤«×¦Ü­««×¬¡°Ê©Ê¼ìºÅ©Êµ²¸zª¢ªº¦¨¦~±wªÌ¡A¹ï§K¬ÌªvÀø¤ÏÀ³¤£¥R¤ÀªÌ¡C
¹ï§K¬Ì§í»s¾¯¦p¥Ö½èÃþ©T¾J¡B´áªãµ¥¤ÏÀ³¤£¥R¤Àªº¤¤­««×¬¡°Ê©Ê¼ìºÅ©Êµ²¸zª¢ªº¦¨¤H±wªÌ¡A»¤¾É©Mºû«ùÁ{§É½w¸Ñ¡C
¥Ö½èÃþ©T¾J¡B²¸ÐüáIËï©Î6-ÝW°òáIËï¡]6-MP¡^µ¥§K¬Ì§í»s¾¯¤ÏÀ³¤£¥R¤Àªº¤¤­««×¬¡°Ê©Ê¼ìºÅ©Êµ²¸zª¢¦¨¦~±wªÌ¡Cªü¹F¤ì³æ§Ü²£«~ªº¦³®Ä©Ê
ªü¹F¤ì³æ§Ü²£«~ªº¦³®Ä©Ê©|¥¼¦b¥H¤U±wªÌ¤¤±o¨ìÃÒ¹ê
¹ïTNFªýÂ_¾¯¥¢¥h¤ÏÀ³©Î¤£­@¨üªº±wªÌ¡Aªü¹F¤ì³æ§Ü²£«~ªº¦³®Ä©Ê©|¥¼½T©w¡C
- ´³¶ôª¬»È®h¯f¡]Ps¡^¡]1.7¡^¡CªvÀø±w¦³¤¤«×¦Ü­««×ºC©Ê´³¶ôª¬»È®h¯fªº¦¨¦~±wªÌ¡C
¤¤«×¦Ü­««×ºC©Ê´³¶ôª¬»È®h¯f±wªÌªºªvÀø¡C
´³¶ôª¬»È®h¯f(Ps)(1.7)¡GªvÀø¤¤«×©M­««×ºC©Ê´³¶ôª¬»È®h¯fªº¦¨¦~±wªÌ¡A³o¨Ç±wªÌ¾A¦X¨Ï¥Î¨t²ÎªvÀø©Î¥úÀø¡A¨Ã¥B¨ä¥L¨t²ÎªvÀø¤èªk¦bÂå¾Ç¤W¨Ã¤£¦X¾A¡C
Âå¾Ç¤W¤£¦X¾A¡C

Rheumatoid Arthritis (RA) (1.1): Reducing signs and symptoms,
inducing major clinical response, inhibiting the progression of structural
damage, and improving physical function in adult patients with
moderately to severely active RA.
• Juvenile Idiopathic Arthritis (JIA) (1.2): Reducing signs and
symptoms of moderately to severely active polyarticular JIA in patients
4 years of age and older.
• Psoriatic Arthritis (PsA) (1.3): Reducing signs and symptoms,
inhibiting the progression of structural damage, and improving physical
function in adult patients with activePsA.
• Ankylosing Spondylitis (AS) (1.4): Reducing signs and symptoms in
adult patients with active AS.
• Adult Crohn¡¦s Disease (CD) (1.5): Reducing signs and symptoms and
inducing and maintaining clinical remission in adult patients with
moderately to severely active Crohn¡¦s disease who have had an
inadequate response to conventional therapy. Reducing signs and
symptoms and inducing clinical remission in these patients if they have
also lost response to or are intolerant to infliximab.
• Ulcerative Colitis (UC) (1.6): Inducing and sustaining clinical remission
in adult patients with moderately to severely active ulcerative colitis who
have had an inadequate response to immunosuppressants such as
corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The
effectiveness of adalimumab products has not been established in patients
who have lost response to or were intolerant to TNF blockers.
• Plaque Psoriasis (Ps) (1.7): The treatment of adult patients with
moderate to severe chronic plaque psoriasis who are candidates for
systemictherapy or phototherapy, and when other systemic therapies are
medicallyless appropriate.
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Herceptin ¶PÀù¥­
1999¦~FDA ®Ö­ã¤W¥«,

2019¦~¬ü°ê ²Ä¤@­ÓHerceptin ¶PÀù¥­¬Û¦üÃľP°â.

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Hurmira FDA 2002¦~12¤ë31¤é®Ö­ã¤W¥«
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Hurmira §Q¥Î±M§Q¤Î¨ä¥L¾AÀ³¯g«OÅ@¡Aª½¨ì±M§Q¨ì´Áªº
2023¦~²Ä¤@­ÓHurmira¬Û¦üÃĤ~¯à¦b¬ü°ê¾P°â¡C

¬ü°ê«OÅ@´Á¦X­p20¦~.

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ibmi.taiwan-healthcare.org/zh/news_detail.php?REFDOCTYPID=0o4dd9ctwhtyumw0&REFDOCID=0r17acjpb7mxy46z

www.genetinfo.com/investment/featured/item/7060.html

Hurmira ¥Íª«¬Û¦üÃÄ

Hurmira FDA 2002¦~12¤ë31¤é®Ö­ã¤W¥«
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2023¦~²Ä¤@­ÓHurmira¬Û¦üÃĤ~¯à¦b¬ü°ê¾P°â¡C
2016¦~¨ÓFDA¤w®Ö­ã6­ÓHurmira ¤W¥«¡A¥u¬OµLªk¦b¬ü¤W¥«¡C

Dupilumab ¬ü°ê 12¦~销°â±M§Q´Á¡A2029/03¦~¨ì´Á¡C

¥i¯à§Q¥Î±M§Q¤Î¨ä¥L¾AÀ³¯g¡A¥i¯à©µªø¦b¬ü°ê¥«³õ¨ì2036¦~¥H¤W¤W¡Aªý¬Û¦üÃĦb¬ü°ê¤W¥«¡C
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ASLAN004 AD 2b Á{§É

¨Ì¾Ú¥Ø«e¥b­Ó¤ë¶}15­Ó¦¬®×¤¤¤ß³t«×,²Ö­p100­Ó¦¬®×¤¤¤ß¥i±æ¦b7¤ëªì§¹¦¨.
¦p¦¹8¤ë¤¤¦¯¦¬®×§¹¦¨ + 4­Ó¤ëªvÀø,12¤ë¤¤¦¯,¥i§¹¦¨¥D­n¼Æ¾Ú¦¬¶°.
Estimated Primary Completion Date : December 15, 2022
-----12¤ë¤¤¦¯«áÀH®É¥i¸Ñª¼,À³¥i¦p´Á§¹¦¨.-----

Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 295 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Trial to Evaluate the Efficacy and Safety of ASLAN004 in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date : March 16, 2022
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : April 15, 2023

clinicaltrials.gov/ct2/show/NCT05158023
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clinicaltrials.gov/ct2/show/NCT01859988?term=NCT01859988&draw=2&rank=1

Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

tudy Design
Go to sections
Study Type : Interventional (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of Dupilumab (REGN668) Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Study Start Date : May 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : September 2014

DUPILUMAB AD 2B
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Dupilumab ¤G´Á AD ¦¬®×¤Î¨ä¥L·sÃĬù59~60¦¬®×¤¤¤ß.

¦X²z¤WASLAN004 ¥çÀ³59­Ó¦¬®×¤¤¤ß*1/5²Õ=295¤H,
¬O§_¦p¤½¥q«ÅºÙ¼W¨ì100­Ó¦¬®×¤¤¤ß,ªñDUPILUMAB¤T´Á¦¬®×¤¤¤ß,³Ì«á¤~ª¾.

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¼W¥[¦¬®×¤¤¤ß,¤]³\¥Î·N¦b³ÌªñDUPILUMAB ¤T´Á¦¬®×¤À°t, §CTRAC/IgE ´î¤Ö©Î°ò½u¥­§¡©Ô°ª¨ìEASI25,
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ASLAN004 AD 2b Á{§É:(§ó·s)

¦¬®×¤¤¤ß¼W¥[¡A¬ü°ê¦A¼W16³B¡A¥þ²y²Ö­p36³B¡C

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---------------

CBP-307 0.2²@§Jªº¬I¥Îªí©ú¡A¦b²Ä12©P¡AÓì应©Ê±ö奥评¤À从°ò线ªº³Ì¤p¤G­¼ªk¡]LS¡^¥­§¡变¤Æªº¥D­n终点数¦rú£¤Ö¡A¦ý没¦³达¨ì统计学·Núå
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2022¦~5¤ë3¤é¡AConnect Biopharma Holdings Limited¡]¤½¥q¡^«Å¥¬¤FCBP-307¡]CBP-307CN002¡^²Ä¤G阶¬q试验12©Pªº³Ì°ª结ªG¡A这¬O¤@Ïú¨C¤é¤@¦¸¡B¤fªAªº选择©ÊÀT®ò¾J1-ÁC»Ä¨üÊ^调节剂¡A¥¿¦b开发¥Î¤_ªv疗溃疡©Ê结肠ª¢¡]UC¡^¡C

CBP-307 0.2²@§Jªº¬I¥Îªí©ú¡A¦b²Ä12©P¡AÓì应©Ê±ö奥评¤À从°ò线ªº³Ì¤p¤G­¼ªk¡]LS¡^¥­§¡变¤Æªº¥D­n终点数¦rú£¤Ö¡A¦ý没¦³达¨ì统计学·Núå¡CÉO¦w¼¢剂¬Û¤ñ¡A±µ¨üCBP-307 0.2²@§J剂¶qªº±wªÌ¤¤¡A®ÚÕu§¹¾ãªº©MÓì应©ÊªºMayo评¤À¡A达¨ì临§É缓¸Ñªº¤ñ¨Ò©ú显§ó°ª¡C¦¹¥~¡A±µ¨üCBP-307 0.2²@§Jªº¤Hªº²O¤Ú细­M计数ú£¤Ö¡A证实¤FCBP-307¦b¬¡动©ÊUC±wªÌ¤¤ªº药®Ä学¬¡©Ê¡C¤½¥q¥´ºâ´NCBP-307ªº¥¼来发®i进¦æ¦X§@讨论¡A¥H¶°¤¤资·½¥Î¤_¨ä¥D导项¥ØCBP-201¡A¤@ÏúIL4Ra«ú§Ü剂¡C

CBP-307 0.2²@§J©M¦w¼¢剂¦b²Ä12©PÓì应±ö奥评¤À¡]¤j«K¦¸数¡Bª½肠¥X¦å©M内镜检¬d评¤À¡^ªºLS¥­§¡变¤Æªº¥D­n终点¤À别为-2.65©M-2.01¡]P=0.103¡^¡C

CBP-307 0.2²@§J达¨ìªº¦¸­n终点¥]¬A¡GÉO¦w¼¢剂¬Û¤ñ¡A达¨ì临§É缓¸Ñªº±wªÌ¤ñ¨Ò©ú显较°ª¡A¤À别¥HÓì应©Ê¡]28.3% vs 9.6%¡A®tÉÝ=18.7¡Fp=0.016¡^©M§¹¥þMayo评¤À¡]18.9% vs 5.8%¡A®tÉÝ=13.1¡Fp=0.044¡^¿Å¶q¡C对¤_±µ¨üCBP-307 0.2²@§Jªº±wªÌ¡A从°ò线¨ì²Ä12©P¡A§¹¾ãªºMayo评¤À¡]§ï编ªºMayo评¤ÀÉO医¥Íªº¥þ²y评¦ô¡^ªº变¤Æ¤]¦³©ú显ªº§ïµ½¡]CBP-307 vs. ¦w¼¢剂ªºLS¥­§¡从°ò线变¤Æ¡G-3.67 vs -2.74¡Ap=0.050¡^©M§¹¾ãMayo评¤À¿Å¶qªº临§É¤Ï应¡]52.8% vs 30.8%¡Ap=0.023¡^¡C¦bCBP-307 0.2²@§J组¤¤¡A观¹î¨ì¥HÓì应©ÊMayo评¤À¿Å¶qªº临§É¤Ï应ªº数¦r§ïµ½¡]54.7% vs 36.5%¡Ap=0.064¡^¡A¦ý没¦³达¨ì统计学·Núå¡C

对¤_CBP-307 0.1²@§J¡AÉO¦w¼¢剂¬Û¤ñ¡A达¨ì临§É缓¸Ñªº±wªÌ¤ñ¨Ò较°ª¡A¤À别¥HÓì应©Ê评¤À¡]12.8% vs 9.6%¡A®tÉÝ=3.5¡Fp=0.601¡^©M§¹¥þMayo评¤À¡]10.3% vs 5.8%¡A®tÉÝ=4.8¡Fp=0.397¡^¿Å¶q¡A¦ý¤£²Å¦X统计学·Núå¡C¦b¥»组¤¤¡A¥H§¹¾ãMayo评¤À¿Å¶qªº临§É¤Ï应¦³数¦r¤Wªº§ïµ½¡]33.3% vs 30.8%¡AP=0.760¡^¡A¦ý¤£²Å¦X统计学·Núå¡C¦bCBP-307 0.1²@§J组¤¤¡A没¦³观¹î¨ì¥HÓì应©ÊMayo评¤À¿Å¶qªº临§É¤Ï应ªº§ïµ½¡]33.3% vs 36.5%¡Ap=0.784¡^¡C

±´¯Á©Ê药®Ä学终点¤ÀªR显¥Ü¡A±µ¨üCBP-307 0.2²@§J©M0.1²@§Jªº±wªÌ¡A¦b²Ä12©P时¡A¥­§¡²O¤Ú细­M计数¤ñ°ò线ú£¤Ö51.3%©M42.7%¡A¥­§¡绝对²O¤Ú细­M计数¤À别ú£¤Ö¨ì约0.8¡]109/L¡^©M1.0¡]109/L¡^¡C

¦bCBP-307 0.2²@§J¡BCBP-307 0.1²@§J©M¦w¼¢剂组¤¤¡A药ª«¬Û关ªºªv疗¬ð发¤£¨}¨Æ¥ó¡]TEAEs¡^ªº发¥Í²v¤À别为66.0%¡B59.0%©M38.5%¡C¦¹¥~¡ACBP-307 0.2²@§J组©M¦w¼¢剂组¦b3级©Î§ó°ªªºTEAEs¡]¤À别为7.5% vs 7.7%¡^©M严­«TEAEs¡]¤À别为3.8% vs 5.8%¡^ªº发¥Í²v¤è­±¬Û¦ü¡C对¤_CBP-307 0.1²@§J¡A3级©Î¥H¤WTEAEs©M严­«TEAEsªº发¥Í²v¤À别为25.6%©M15.4%¡C¦bCBP-307 0.2²@§J©MCBP-307 0.1²@§J组¤¤¡AÉO药ª«¬Û关ªº3级©Î§ó°ªTEAEsªº发¥Í²v¤À别为5.7%©M12.8%¡AÉO药ª«¬Û关ªº严­«TEAEsªº发¥Í²v¤À别为1.9%©M5.1%¡A¦Ó¦b¦w¼¢剂组¤¤没¦³发现¦¹类TEAEs¡C没¦³¥X现进¦æ©Ê¦h¨_©Ê¥Õ质脑¯fªº¯f¨Ò¡A¤]没¦³¦º¤`¯f¨Ò¡C这项¬ã¨sªº总Ê^¦w¥þ©Ê结ªG显¥Ü¡ACBP-307¦b¤¤«×¦Ü­««×UC±wªÌ¤¤ªº­@¨ü©Ê´¶¹M¨}¦n¡C鉴¤_这项¬ã¨sªº¦w¥þ©Ê©M疗®Ä结ªG¡A¤½¥q认为CBP-307­È±o对UC进¦æ进¤@¨B临§É开发¡C

On May 3, 2022, Connect Biopharma Holdings Limited (the ¡§Company¡¨) announced top-line results at 12 weeks from its Phase 2 trial for CBP-307 (¡§CBP-307CN002¡¨), a once-daily, orally administered, selective sphingosine 1-phosphate receptor modulator in development for the treatment of ulcerative colitis (¡§UC¡¨).

Administration of CBP-307 0.2 mg demonstrated a numerical reduction for the primary endpoint of least squares (¡§LS¡¨) mean change from baseline in adapted Mayo Score at Week 12 that did not meet statistical significance. A significantly higher proportion of patients who received CBP-307 0.2 mg dose achieved Clinical Remission as compared to placebo based on both the complete and adapted Mayo Scores. Additionally, reductions in lymphocyte counts amongst individuals receiving CBP-307 0.2 mg confirmed pharmacodynamic activity of CBP-307 in patients with active UC. The Company intends to engage in partnership discussions for the future development of CBP-307 to focus resources on its lead program CBP-201, a IL4Ra antagonist.

The primary endpoint of LS mean change from baseline in adapted Mayo Score (stool frequency, rectal bleeding, and endoscopy scores) at Week 12 for CBP-307 0.2 mg and placebo were -2.65 and -2.01, respectively (p=0.103).

Secondary endpoints that were met for CBP-307 0.2 mg included a significantly higher proportion of patients reaching Clinical Remission compared to placebo as measured by both adapted (28.3% vs 9.6%, difference=18.7; p=0.016) and complete Mayo Scores (18.9% vs 5.8%, difference=13.1; p=0.044), respectively. For patients receiving CBP-307 0.2 mg, significant improvements were also noted for change in complete Mayo Score (adapted Mayo Score with physician¡¦s global assessment) from baseline to Week 12 (LS Mean Change from Baseline for CBP-307 vs. placebo: -3.67 vs -2.74, p=0.050) and in Clinical Response as measured by complete Mayo Score (52.8% vs 30.8%, p=0.023). A numerical improvement in Clinical Response as measured by adapted Mayo Score (54.7 % vs 36.5%, p=0.064) was observed in the CBP-307 0.2 mg group that did not meet statistical significance.

For CBP-307 0.1 mg, a numerically higher proportion of patients reached Clinical Remission compared to placebo as measured by both adapted (12.8% vs 9.6%, difference=3.5; p=0.601) and complete Mayo Scores (10.3% vs 5.8%, difference=4.8; p=0.397), respectively, that did not meet statistical significance. In this group, numerical improvements were noted for Clinical Response as measured by complete Mayo Score (33.3% vs 30.8%, p=0.760) that did not meet statistical significance. No improvement in Clinical Response as measured by adapted Mayo Score (33.3% vs 36.5%, p=0.784) was observed in the CBP-307 0.1 mg group.

Analysis of exploratory pharmacodynamic endpoints showed that patients receiving CBP-307 0.2 mg and 0.1 mg demonstrated a mean percent lymphocyte count reduction from baseline of 51.3% and 42.7% with mean absolute lymphocyte counts reduced to approximately 0.8 (109/L) and 1.0 (109/L), respectively, at Week 12.

Across the CBP-307 0.2 mg, CBP-307 0.1 mg, and placebo groups, the occurrence of drug-related treatment emergent adverse events (¡§TEAEs¡¨) was 66.0%, 59.0%, and 38.5%, respectively. In addition, CBP-307 0.2 mg and placebo groups were similar in the occurrence of Grade 3 or higher TEAEs (7.5% vs 7.7%, respectively) and Serious TEAEs (3.8% vs 5.8%, respectively). For CBP-307 0.1 mg, the rates of Grade 3 or higher TEAEs and Serious TEAEs were 25.6% and 15.4%, respectively. Across the CBP-307 0.2 mg and CBP-307 0.1 mg groups, the occurrence of drug-related Grade 3 or higher TEAEs was 5.7% and 12.8%, respectively, and the occurrence of drug-related Serious TEAEs was 1.9% and 5.1%, respectively, and no such TEAEs were observed in the placebo group. There were no cases of progressive multifocal leukoencephalopathy and no deaths. The overall safety results in this study showed CBP-307 to be generally well tolerated in patients with moderate-to-severe UC. Given the safety findings along with the efficacy results of this study, the Company believes that CBP-307 warrants further clinical development in UC.
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Tang Capital Management is based out of San Diego. Their last reported 13F filing for Q4 2021 included $497,219,000 in managed 13F securities and a top 10 holdings concentration of 77.0%. Tang Capital Management¡¦s largest holding is AnaptysBio Inc with shares held of 2,628,678. Tang Capital Management has met the qualifications for inclusion in our WhaleScore system. Whalewisdom has at least 41 13F filings, and 2 13G filings

Tang Capital Management Á`³¡¦ì©ó¸t¦a¨È­ô¡C ¥L­Ì¤W¦¸³ø§iªº 2021 ¦~²Ä¥|©u«×ªº 13F ¥Ó³ø¥]¬A 497,219,000 ¬ü¤¸ªº°UºÞ 13F ÃÒ¨é©M 77.0% ªº«e 10 ¦W«ùªÑ¶°¤¤«×¡C Tang Capital Management³Ì¤j«ùªÑ¬°AnaptysBio Inc¡A«ùªÑ2,628,678ªÑ¡C ­ð¸ê¥»ºÞ²z¤w¹F¨ì¯Ç¤J§Ú­ÌWhaleScore¨t²Îªº¸ê®æ¡C Whalewisdom ¦Ü¤Ö¦³ 41 ­Ó 13F ¤å¥ó©M 2 ­Ó 13G ¤å¥ó

whalewisdom.com/filer/tang-capital-management-llc#tabholdings_tab_link
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TANG (­ð) CAPITAL MANAGEMENT LLC ¤F¸Ñ¤@¤U³o®a§ë¸ê¾÷ºc¦³X¸ê­I´º¶Ü? ¦pªG¦³°h³õ­·ÀI¤j

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Dupilumab ¤T´Á/2­ÓÁ{§Ésolo1/solo2

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n = 66 n = 73 n = 81
EASI score, mean (SD) 26.2 (9.8)/ 25.0 (9.6) /28.3 (12.5)
CCL17 levels, mean (SD), pg/mL 1,467.6 (2,787.3) /2,281.9 (5,052.9)/ 2,295.0 (6,306.8)
Total IgE levels, mean (SD), kU/L 59.0 (40.3)/ 55.1 (41.9) /57.6 (44.7)

(2) IgE >= 150 kU/L

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n = 393 n = 384 n = 381
EASI score, mean (SD) 35.4 (14.6)/ 33.8 (13.5) /33.4 (13.4)
CCL17 levels, mean (SD) 6,668.9 (10,987.1)/ 7,531.0 (15,176.1)/ 6,886.3 (12,413.0)
Total IgE levels, mean (SD) 8,131.7 (10,649.3)/ 8,063.9 (11,034.3) /6,609.7 (9,916.7)

-------------------------
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Dupilumab ¦U´ÁÁ{§É¼Æ¾Ú¡C

1. Dupilumab ¦­´Á¥|­Ó AD Á{§É 4¶g/12¶g ,
2014/07/10

Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis

www.nejm.org/doi/10.1056/NEJMoa1314768

2. Dupilumab 2a/2b Á{§É ,2018/SEP

journals.lww.com/jaanp/Fulltext/2018/09000/Efficacy_and_safety_of_dupilumab_for_the_treatment.10.aspx

3.Dupilumab AD 2­Ó¤T´ÁÁ{§É, 300mg/¨C¶g¤@°w/300mg/¨C¤G¶g¤@°w
2016/12/15

Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis
www.nejm.org/doi/full/10.1056/nejmoa1610020
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ASLN ­è­è¤½¥¬2022Q1°]°È³øªí¤Î¥¼¨Óµo®i

Anticipated upcoming milestones

Initiation of Phase 2 study of farudodstat, also known as ASLAN003, in inflammatory bowel disease is planned for the first half of 2022.

New data on biomarkers and patient reported outcome measures from the Phase 1b proof-of-concept study of eblasakimab expected in the second half of 2022.

Topline data from the Phase 2b TREK-AD study of eblasakimab is expected in the first half of 2023.
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eblasakimab 2b ´Á TREK-AD ¬ã¨sªº¤@½u¼Æ¾Ú¹w­p±N¦b 2023 ¦~¤W¥b¦~µo¥¬¡C
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ASLN ³Ì¤jªÑªF,«ùªÑ5.4%
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Tang Capital Partners. Tang Capital Partners beneficially owns 18,796,125 Ordinary Shares of the Issuer, in the form of 3,759,225 ADSs.

TANG CAPITAL PARTNERS, LP


whalewisdom.com/stock/asln
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CNTB - Connect Biopharma Holdings Limited

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sec.report/Document/0001193125-22-106928/

CNBT ¦b¥|¤ë¤Q¤­¤é¡]¤W¶g¡^¡A°e¥X¤T»õ¬ü¤¸ªº¶Ò¸ê­p¹º¡A·Ç³Æ°µCBP201 AD ¤T´ÁÁ{§É¡C

Business Overview
We are a global clinical-stage biopharmaceutical company developing therapies for the treatment of T cell-driven inflammatory diseases. Our core expertise is in the use of functional cellular assays with T cells to screen and discover potent product candidates against immune targets. Our two most advanced clinical-stage programs include highly differentiated product candidates against validated targets. Our lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha, or IL-4Ra, which is a validated target for the treatment of inflammatory diseases such as atopic dermatitis, or AD, and asthma. The estimated global market for AD was approximately $7.6 billion in 2021 and is expected to grow to $12.1 billion by 2025, a compound annual growth rate, or CAGR, of 12.4%. Based on observed results in preclinical studies and clinical trials, CBP-201 has the potential to be differentiated from dupilumab, an antibody that also targets IL-4Ra, which is now approved by the U.S. Food and Drug Administration, or FDA. We recently completed a Phase 2b trial of CBP-201 in the United States, Australia and New Zealand in adult patients with moderate-to-severe AD, in which primary and key secondary endpoints were met, and plan to initiate a global Phase 3 program in adult patients with moderate-to-severe AD in the second half of 2022. We are also currently conducting a Phase 2b trial evaluating CBP-201 in Type 2 inflammatory asthma and chronic rhinosinusitis with nasal polyps, or CRSwNP, and a pivotal trial in moderate-to-severe AD patients in the PRC. Furthermore, we are developing CBP-307, a modulator of a T cell receptor known as sphingosine 1-phosphate receptor 1, or S1P1, for the treatment of inflammatory bowel disease, or IBD. Specifically, we are developing CBP-307 for two types of IBD, ulcerative colitis, or UC, and Crohn¡¦s disease, or CD. We anticipate reporting top-line results from a global Phase 2 trial in UC in the second quarter of 2022, while we will determine whether to initiate further clinical trials in CD after evaluating the Phase 2 UC data.
Our immune modulator product candidates originate from our approach to drug discovery based on using biologically relevant functional cellular assays to conduct primary drug screens instead of high-throughput biochemical assays. The clinical and preclinical results we have observed for our product candidates support the potential for this physiologically relevant methodology to yield highly differentiated solutions, in a more efficient manner. Our approach is agnostic to drug modalities and has been used to identify both small molecule and antibody product candidates.
We are advancing CBP-201, an investigational anti-IL-4Ra antibody, for the treatment of inflammatory allergic diseases such as AD, asthma and CRSwNP. Inhibition of IL-4Ra blocks the action of two inflammatory cytokines: interleukin- 4, or IL-4, and interleukin-13, or IL-13. In a randomized, placebo-controlled Phase 1a trial in healthy volunteers, administration of a single dose of CBP-201 was well-tolerated and led to suppression of a serum biomarker of inflammation. In a randomized, double-blinded placebo-controlled Phase 2b trial in adult AD patients, we observed significant improvements in primary and key secondary endpoints on skin clearance, disease severity, and itch, and CBP-201 was generally well-tolerated. Although no head-to-head trials have been conducted, we believe that CBP-201 has two potential advantages over the current standard of care: (1) in preclinical studies CBP-201 bound to a region of IL-4Ra that is distinct from that bound by dupilumab and associated with high binding affinity and potency for IL-4Ra, which we believe may lead to improved clinical response; and (2) a more convenient proposed dosing regimen in adult patients with moderate to severe AD, as evidenced by our Phase 2b trial data showing positive results with our Q4W (300 mg dose every four weeks) results, which is a less frequent dosing schedule than the Q2W (300 mg dose every two weeks) dose for duplimab for adult patients with moderate to severe AD.
CBP-307 is an investigational, small molecule modulator of S1P1, a regulator of T cell mobilization out of lymph nodes into the periphery. Inhibiting S1P1 leads to reduction in the levels of these T cells in circulation and a reduction in autoimmune-related inflammation. S1P1 is a validated therapeutic target with three drugs approved to treat multiple sclerosis: fingolimod, marketed as Gilenya® by Novartis, siponimod, marketed as Mayzent® by Novartis, and ozanimod, marketed as Zeposia®, by Bristol Myers Squibb. Evidence from third-party clinical trials suggests that the potential of S1P1 modulators is far broader than multiple sclerosis and includes highly prevalent diseases with unmet need such as UC and CD, and Zeposia received approval for the


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¦¹¥~¡A§Ú­Ì¥¿¦b¶}µo CBP-307¡A¤@ºØ T ²Ó­M¨üÅ骺½Õ¸`¾¯¡AºÙ¬° 1-ÁC»ÄÀT®ò¾J¨üÅé 1¡A©Î S1P1¡A¥Î©óªvÀøª¢¯g©Ê¸z¯f©Î IBD¡C

¨ãÅé¨Ó»¡¡A§Ú­Ì¥¿¦b¬°¨âºØÃþ«¬ªº IBD¡B¼ìºÅ©Êµ²¸zª¢©Î UC ©M§Jù®¦¯f©Î CD ¶}µo CBP-307¡C§Ú­Ì¹w­p¦b 2022 ¦~²Ä¤G©u«×³ø§i¥þ²y UC 2 ´Á¸ÕÅ窺¤@½uµ²ªG¡A¦P®É§Ú­Ì±N¦bµû¦ô 2 ´Á UC ¼Æ¾Ú«á½T©w¬O§_¦b CD ¤¤±Ò°Ê¶i¤@¨BªºÁ{§É¸ÕÅç¡C


§Ú­Ìªº§K¬Ì½Õ¸`¾¯­Ô¿ï²£«~·½©ó§Ú­ÌªºÃĪ«µo²{¤èªk¡A¸Ó¤èªk°ò©ó¨Ï¥Î¥Íª«¾Ç¬ÛÃöªº¥\¯à©Ê²Ó­M´ú©w¨Ó¶i¦æªì¯ÅÃĪ«¿z¿ï¡A¦Ó¤£¬O°ª³q¶q¥Í¤Æ´ú©w¡C§Ú­Ì¬°­Ô¿ï²£«~Æ[¹î¨ìªºÁ{§É©MÁ{§É«eµ²ªG¤ä«ù³oºØ¥Í²z¬ÛÃö¤èªk¥H§ó¦³®Äªº¤è¦¡²£¥Í°ª«×®t²§¤Æ¸Ñ¨M¤è®×ªº¼ç¤O¡C§Ú­Ìªº¤èªk»PÃĪ«§Î¦¡µLÃö¡A¨Ã¤w¥Î©óÃѧO¤p¤À¤l©M§ÜÅé²£«~­Ô¿ïªÌ¡C

§Ú­Ì¥¿¦b±À¶i CBP-201¡A¤@ºØ¦b¬ã§Ü IL-4Ra §ÜÅé¡A¥Î©óªvÀøª¢¯g©Ê¹L±Ó©Ê¯e¯f¡A¦p AD¡B­ý³Ý©M CRSwNP¡C§í¨î IL-4Ra ·|ªýÂ_¨âºØª¢©Ê²Ó­M¦]¤lªº§@¥Î¡G¥Õ²Ó­M¤¶¯À 4 ©Î IL-4 ©M¥Õ²Ó­M¤¶¯À 13 ©Î IL-13¡C¦b¤@¶µ°w¹ï°·±d§ÓÄ@ªÌªºÀH¾÷¡B¦w¼¢¾¯¹ï·Óªº 1a ´Á¸ÕÅ礤¡A³æ¾¯¶q CBP-201 ªºµ¹ÃÄ­@¨ü©Ê¨}¦n¡A¨Ã¾É­P§í¨î¦å²Mª¢¯g¥Íª«¼Ð»xª«¡C¦b¤@¶µ°w¹ï¦¨¤H AD ±wªÌªºÀH¾÷¡BÂùª¼¦w¼¢¾¯¹ï·Ó 2b ´Á¸ÕÅ礤¡A§Ú­ÌÆ[¹î¨ì¥Ö½§²M°£¡B¯e¯fÄY­«µ{«×©Mæ±Äoµ¥¥D­n©MÃöÁ䦸­n²×ÂIªºÅãµÛ§ïµ½¡A¨Ã¥B CBP-201 ³q±`¨ã¦³¨}¦nªº­@¨ü©Ê¡CÁöµM¨S¦³¶i¦æ¹LÀY¹ïÀY¸ÕÅç¡A¦ý§Ú­Ì»{¬° CBP-201 »P·í«eªºÅ@²z¼Ð·Ç¬Û¤ñ¨ã¦³¨â­Ó¼ç¦bÀu¶Õ¡G

(1) ¦bÁ{§É«e¬ã¨s¤¤¡ACBP-201 »P IL-4Ra °Ï°ì¤£¦P¡A»P»P dupilumab µ²¦X¨Ö»P IL-4Ra ªº°ªµ²¦X¿Ë©M¤O©M®Ä¤O¬ÛÃö¡A
§Ú­Ì»{¬°³o¥i¯à·|§ïµ½Á{§É¤ÏÀ³¡F (2) ¤¤«×¦Ü­««× AD ¦¨¦~±wªÌ§ó¤è«Kªºµ¹ÃĤè®×¡A§Ú­Ìªº 2b ´Á¸ÕÅç¼Æ¾ÚÅã¥Ü§Ú­Ìªº Q4W¡]¨C 4 ¶g 300 ²@§J¾¯¶q¡^µ²ªGÅã¥Ü¶§©Êµ²ªG¡A³o¬O¤@ºØÀW²v¸û§Cªºµ¹ÃĤè®×¤ñ duplimab ¥Î©ó¤¤«×¦Ü­««× AD ¦¨¤H±wªÌªº Q2W¡]¨C¨â¶g 300 mg ¾¯¶q¡^¾¯¶q¡C

CBP-307 ¬O S1P1 ªº¬ã¨s©Ê¤p¤À¤l½Õ¸`¾¯¡AS1P1 ¬O T ²Ó­M±q²O¤Úµ²Âಾ¨ì¥~©Pªº½Õ¸`¾¯¡C§í¨î S1P1 ·|¾É­P´`Àô¤¤³o¨Ç T ²Ó­M¤ô¥­ªº­°§C©M¦Û¨­§K¬Ì¬ÛÃöª¢¯gªº´î¤Ö¡C S1P1 ¬O¤@ºØ¸g¹LÅçÃÒªºªvÀø¹vÂI¡A¤TºØÃĪ«Àò§å¥Î©óªvÀø¦hµo©Êµw¤Æ¯g¡Gªâ¤à²ö¼w¡A¿ÕµØ¤½¥q¥H Gilenya® ¾P°â¡A¨¯ªi²ö¼w¡A¿ÕµØ¤½¥q¥H Mayzent® ¾P°â¡A¥H¤Î ozanimod¡A¦Ê®É¬ü¬I¶QÄ_¥H Zeposia® ¾P°â¡C¨Ó¦Û²Ä¤T¤èÁ{§É¸ÕÅ窺ÃÒ¾Úªí©ú¡AS1P1 ½Õ¸`¾¯ªº¼ç¤O»·¤ñ¦hµo©Êµw¤Æ¯g§ó¼sªx¡A¥]¬A°ª«×¬y¦æ¦ý»Ý¨D¥¼±o¨ìº¡¨¬ªº¯e¯f¡A¦p UC ©M CD¡AZeposia Àò±o¤F§å­ã

The estimated global market for UC was approximately $5.4 billion in 2021, and the estimated global market for CD was approximately $5.4 billion in 2020. We believe that CBP-307 is well-positioned to potentially address these diseases due to the potency, specificity and pharmacokinetics observed in our preclinical studies and early clinical trials. We are conducting a global Phase 2 trial in UC and anticipate reporting top-line results before the end of the second quarter of 2022. In addition, we intend to initiate a global clinical trial in CD based on the preliminary clinical responses observed in a limited number of patients in an earlier CD clinical trial.
2021 ¦~ UC ªº¥þ²y¥«³õ¦ô­p¬ù¬° 54 »õ¬ü¤¸¡A2020 ¦~ CD ªº¥þ²y¥«³õ¦ô­p¬ù¬° 54 »õ¬ü¤¸¡C§Ú­Ì»{¬°¡A¥Ñ©ó®Ä¤O¡B¯S²§©Ê©MÃÄ¥N°Ê¤O¾Ç¡ACBP-307 ¦³¥i¯à¸Ñ¨M³o¨Ç¯e¯f ¦b§Ú­ÌªºÁ{§É«e¬ã¨s©M¦­´ÁÁ{§É¸ÕÅ礤Æ[¹î¨ì¡C §Ú­Ì¥¿¦b UC ¶}®i¤@¶µ¥þ²y 2 ´Á¸ÕÅç¡A¨Ã¹w­p¦b 2022 ¦~²Ä¤G©u«×¥½¤§«e³ø§i¤@½uµ²ªG¡C¦¹¥~¡A§Ú­Ì¥´ºâ®Ú¾Ú¦b¦³­­½d³ò¤ºÆ[¹î¨ìªºªì¨BÁ{§É¤ÏÀ³±Ò°Ê¤@¶µ°w¹ï CD ªº¥þ²yÁ{§É¸ÕÅç ¦­´Á CD Á{§É¸ÕÅ礤ªº±wªÌ¤H¼Æ¡C
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To:«Ó°¶¤j
¤@¯ë¨Ó»¡²Ö¿n¨ì¤@©wª¼¼Æ¾Úªº¶q(¦p¦¬®×¤@¥b¥H¤W¥B§¹¦¨¥D­n¸ÕÅç¶µ¥Ø)¡A¦p¼Æ¾Ú¨«¦V¦p¤½¥q¹w´Á¥¿¦V¡A¬°©Ô©ï¤½¥q¥«­È¡A99%ªº¤½¥q³£·|¤½¥¬´Á¤¤¼Æ¾Ú¡A§Æ±æªü·àªº°ª¼h¤]¬O¦p¦¹¥´ºâ~
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·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2022/4/19 ¤U¤È 05:28:41²Ä 5231 ½g¦^À³

Lebrikizumab 2B clients Actual Primary Completion Date : February 7, 2019

Almirall ©M Dermira ´N Lebrikizumab ªº¼Ú¬wÅv§Qñ­q¿ï¾ÜÅv©M³\¥i¨óij
February 12, 2019 02:00 ET | Source: Dermira, Inc.

Lebrikizumab 2B 2b ¸Ñª¼«á7¤Ñ±ÂÅv§¹¦¨,

---Dermira ¤½¥q³QLILY¤½¥q¨ÖÁȸg11­Ó¤ë.

---------------------
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------------------------------------------------------------




1. February 12, 2019 02:00 ET | Source: Dermira, Inc.

Almirall and Dermira Enter into Option and License Agreement for European Rights to Lebrikizumab
Almirall ©M Dermira ´N Lebrikizumab ªº¼Ú¬wÅv§Qñ­q¿ï¾ÜÅv©M³\¥i¨óij
February 12, 2019 02:00 ET | Source: Dermira, Inc.


www.globenewswire.com/news-release/2019/02/12/1720494/0/en/Almirall-and-Dermira-Enter-into-Option-and-License-Agreement-for-European-Rights-to-Lebrikizumab.html

2.March 18, 2019 07:00 ET | Source: Dermira, Inc.(
Dermira «Å¥¬ Lebrikizumab ªvÀø¯SÀ³©Ê¥Öª¢±wªÌªº 2b ´Á¬ã¨sªº¶§©Ê³»½uµ²ªG

Dermira Announces Positive Topline Results from Phase 2b Study of Lebrikizumab in Patients with Atopic Dermatitis
March 18, 2019 07:00 ET | Source: Dermira, Inc.

www.globenewswire.com/news-release/2019/03/18/1756186/0/en/Dermira-Announces-Positive-Topline-Results-from-Phase-2b-Study-of-Lebrikizumab-in-Patients-with-Atopic-Dermatitis.html


3.Lebrikizumab 2b Á{§É

clinicaltrials.gov/ct2/show/NCT03443024?term=Lebrikizumab+ad&draw=2&rank=4

Study Type : Interventional (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : February 7, 2019
Actual Study Completion Date : May 23, 2019
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ASLAN004 400 mg q4w - loading doses at Baseline, Week 1 and Week 2, followed by regular doses of 400 mg or alternating placebo (q2W) to Week 14. ...³Qµû¦ô¬°¥¿¦Vªº¸Ü¡AªÑ»ù´N¦³¾÷·|¤jº¦

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·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2022/4/19 ¤U¤È 03:31:21²Ä 5229 ½g¦^À³



1. February 12, 2019 02:00 ET | Source: Dermira, Inc.

Almirall and Dermira Enter into Option and License Agreement for European Rights to Lebrikizumab
Almirall ©M Dermira ´N Lebrikizumab ªº¼Ú¬wÅv§Qñ­q¿ï¾ÜÅv©M³\¥i¨óij
February 12, 2019 02:00 ET | Source: Dermira, Inc.


www.globenewswire.com/news-release/2019/02/12/1720494/0/en/Almirall-and-Dermira-Enter-into-Option-and-License-Agreement-for-European-Rights-to-Lebrikizumab.html

2.March 18, 2019 07:00 ET | Source: Dermira, Inc.(
Dermira «Å¥¬ Lebrikizumab ªvÀø¯SÀ³©Ê¥Öª¢±wªÌªº 2b ´Á¬ã¨sªº¶§©Ê³»½uµ²ªG

Dermira Announces Positive Topline Results from Phase 2b Study of Lebrikizumab in Patients with Atopic Dermatitis
March 18, 2019 07:00 ET | Source: Dermira, Inc.

www.globenewswire.com/news-release/2019/03/18/1756186/0/en/Dermira-Announces-Positive-Topline-Results-from-Phase-2b-Study-of-Lebrikizumab-in-Patients-with-Atopic-Dermatitis.html


3.Lebrikizumab 2b Á{§É

clinicaltrials.gov/ct2/show/NCT03443024?term=Lebrikizumab+ad&draw=2&rank=4

Study Type : Interventional (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : February 7, 2019
Actual Study Completion Date : May 23, 2019
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·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2022/4/19 ¤U¤È 12:38:31²Ä 5226 ½g¦^À³
PRESS RELEASE
ASLAN PHARMACEUTICALS INITIATES PHASE 2B STUDY OF ASLAN004 (EBLASAKIMAB) IN MODERATE-TO-SEVERE ATOPIC DERMATITIS
- The TRials with EblasaKimab in Atopic Dermatitis (TREK-AD) study will evaluate the efficacy and safety of ASLAN004, now known as eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor
- This dose-ranging study is expected to enroll approximately 300 patients and will evaluate 4 dose regimens
- Topline results are expected in 1H 2023
Menlo Park, California, and Singapore, January 20, 2022 ¡V ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that it has screened the first patient in its Phase 2b dose-ranging clinical study of eblasakimab in adults with moderate-to-severe atopic dermatitis (AD). Eblasakimab is a potential first-in-class monoclonal antibody targeting the IL-13 receptor that has the potential to provide a differentiated treatment option for patients. ASLAN expects to report topline findings from the 16-week treatment period in the first half of 2023.
The randomized, double-blind, placebo-controlled, dose-ranging clinical study will evaluate the efficacy and safety of eblasakimab in adult patients with moderate-to-severe AD who are candidates for systemic therapy. The TREK-AD study will randomize patients equally to four active treatment arms and one placebo arm, evaluating eblasakimab 300mg dosed every two weeks, 400mg dosed every two weeks, 400mg dosed every four weeks and 600mg dosed every four weeks.
The study is expected to enroll approximately 300 adult patients across 100 sites in North America, Europe and Asia Pacific and will consist of a 16-week treatment period and a 12-week safety follow-up period.
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ctee.com.tw/news/real-estate/629241.html

ASLAN004 ¤¤-­««×AD 2b Á{§É¼W¥[¤@­Ó·s¥[©Yªº¦¬®×¤¤¤ß¡A²Ö­p20­Ó¦¬®×¤¤¤ß¡C
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clinicaltrials.gov/ct2/show/NCT02277743

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1.ASLN ªº±M®a,¦b¸Ñª¼«e´N­ç°£,«D¶Ç²ÎAD9¤H
¥B¸Ñª¼®É¦P®ÉªþµùDUIPILUMAB ¤T´Á,
Biomarkers CCL17/TARC and Total IgE Do Not Predict Clinical Response to Dupilumab in Atopic Dermatitis (AD): a Post hoc Analysis of Pooled Phase 3 Data (SOLO 1 & 2)
Submitted Sep 2, 2019

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www.morressier.com/article/biomarkers-ccl17tarc-total-ige-not-predict-clinical-response-dupilumab-atopic-dermatitis-ad-post-hoc-analysis-pooled-phase-3-data-solo-1--2/5d4980cb8fb7e44098e72cd2?

Biomarkers CCL17/TARC and Total IgE Do Not Predict Clinical Response to Dupilumab in Atopic Dermatitis (AD): a Post hoc Analysis of Pooled Phase 3 Data (SOLO 1 & 2)
Submitted Sep 2, 2019

Jennifer D. Hamilton
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www.morressier.com/article/biomarkers-ccl17tarc-total-ige-not-predict-clinical-response-dupilumab-atopic-dermatitis-ad-post-hoc-analysis-pooled-phase-3-data-solo-1--2/5d4980cb8fb7e44098e72cd2?

Biomarkers CCL17/TARC and Total IgE Do Not Predict Clinical Response to Dupilumab in Atopic Dermatitis (AD): a Post hoc Analysis of Pooled Phase 3 Data (SOLO 1 & 2)
Submitted Sep 2, 2019

Jennifer D. Hamilton

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www.morressier.com/article/biomarkers-ccl17tarc-total-ige-not-predict-clinical-response-dupilumab-atopic-dermatitis-ad-post-hoc-analysis-pooled-phase-3-data-solo-1--2/5d4980cb8fb7e44098e72cd2?

Biomarkers CCL17/TARC and Total IgE Do Not Predict Clinical Response to Dupilumab in Atopic Dermatitis (AD): a Post hoc Analysis of Pooled Phase 3 Data (SOLO 1 & 2)
Submitted Sep 2, 2019

Jennifer D. Hamilton

Zhen ¡K¡K

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------------------------------------------


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----------------------------------


Lebrikizumab ¤G­Ó¤T´Á¥D­n«ü¼Ð16¶g¡«áÀø®Ä¡C¤@¤@¤@¤@2022AAD¦~·|¤fÀY³ø§i


In ADvocate 1,
43 percent of patients receiving lebrikizumab achieved clear or almost clear skin (IGA) at 16 weeks compared to 13 percent of patients taking placebo.
Among those receiving lebrikizumab, 59 percent achieved an EASI-75 response, compared to 16 percent with placebo.


In ADvocate 2,
33 percent of patients taking lebrikizumab achieved clear or almost clear skin (IGA) at 16 weeks, compared to 11 percent of patients on placebo.
Among those receiving lebrikizumab, 51 percent achieved an EASI-75 response, compared to 18 percent taking placebo.


www.nejm.org/doi/full/10.1056/nejmoa1610020
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In ADvocate 1,
43 percent of patients receiving lebrikizumab achieved clear or almost clear skin (IGA) at 16 weeks compared to 13 percent of patients taking placebo.
Among those receiving lebrikizumab, 59 percent achieved an EASI-75 response, compared to 16 percent with placebo.

In ADvocate 2,
33 percent of patients taking lebrikizumab achieved clear or almost clear skin (IGA) at 16 weeks, compared to 11 percent of patients on placebo.
Among those receiving lebrikizumab, 51 percent achieved an EASI-75 response, compared to 18 percent taking placebo.

¤@¤@¤@¤@¤@¤@
Majority of Patients Treated with Lebrikizumab Achieved Skin Clearance in Lilly¡¦s Pivotal Phase 3 Atopic Dermatitis Studies
Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company)
NEWS PROVIDED BY
Eli Lilly and Company
Mar 26, 2022, 09:20 ET
SHARE THIS ARTICLE

Lebrikizumab rapidly improved skin and itch symptoms in four weeks

INDIANAPOLIS, March 26, 2022 /PRNewswire/ -- More than 50 percent of patients with moderate-to-severe atopic dermatitis (AD) experienced at least 75 percent reduction in disease severity (EASI-75*) at 16 weeks when receiving lebrikizumab monotherapy in the ADvocate program, Eli Lilly and Company (NYSE: LLY) announced today at the American Academy of Dermatology (AAD) Annual Meeting. Lebrikizumab, an investigational IL-13 inhibitor, also led to clinically meaningful improvements in itch and other important patient-reported outcomes compared to placebo.

Patients with atopic dermatitis experience persistent itch, dry skin, severe pain and inflammation, which can be unpredictable and affect their work, social relationships, mental and emotional health, said Emma Guttman-Yassky, M.D., Ph.D., Waldman professor and system chair of Dermatology at the Icahn School of Medicine at Mount Sinai in New York, and senior author of the ADvocate analyses. Lebrikizumab is a novel treatment targeting the IL-13 pathway, which is the main cytokine driver of inflammation that is involved in AD. I¡¦m encouraged by today¡¦s data showing rapid improvements in skin, itch and quality-of-life measures.

Lebrikizumab is a monoclonal antibody (mAb) that binds to the interleukin 13 (IL-13) protein with high affinity to specifically prevent the formation of IL-13R£\1/IL-4R£\ (Type 2 receptor) which blocks downstream signaling through the IL-13 pathway. 1-5 IL-13 plays the central role in Type 2 inflammation.6 In AD, IL-13 underlies the signs and symptoms including skin barrier dysfunction, itch, infection and hard, thickened areas of skin.7

In ADvocate 1, 43 percent of patients receiving lebrikizumab achieved clear or almost clear skin (IGA) at 16 weeks compared to 13 percent of patients taking placebo. Among those receiving lebrikizumab, 59 percent achieved an EASI-75 response, compared to 16 percent with placebo.

In ADvocate 2, 33 percent of patients taking lebrikizumab achieved clear or almost clear skin (IGA) at 16 weeks, compared to 11 percent of patients on placebo. Among those receiving lebrikizumab, 51 percent achieved an EASI-75 response, compared to 18 percent taking placebo.

Within four weeks, patients receiving lebrikizumab experienced statistically significant improvements in skin clearance and itching, as well as improvements in interference of itch on sleep, and quality of life, as measured by key secondary endpoints.

The safety profile of the 16-week period was consistent with prior lebrikizumab studies in AD. Patients taking lebrikizumab, compared to placebo, reported a lower frequency of adverse events in ADvocate 1 (lebrikizumab: 45%, placebo: 52%) and ADvocate 2 (lebrikizumab: 53%, placebo: 66%). Most adverse events across the two studies were mild or moderate in severity and nonserious and did not lead to treatment discontinuation. The most common adverse events in ADvocate 1 and 2 for those on lebrikizumab were conjunctivitis (7% and 8%, respectively), common cold (nasopharyngitis) (4% and 5%, respectively) and headache (3% and 5%, respectively).

People¡¦s experiences and struggles with autoimmune diseases, such as atopic dermatitis, drive us at Lilly to pursue novel science and meaningful treatments that make life better, especially in areas where there is urgent unmet need, said Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and medical affairs at Lilly. These data reinforce the positive results in our broader Phase 3 development program, and we believe lebrikizumab represents a new generation of biologics for AD.

Detailed 52-week results from ADvocate 1 and 2, as well as 16-week data from ADhere, the Phase 3 AD study of lebrikizumab with topical steroids, will be disclosed in coming months. Lilly and Almirall S.A. plan to submit filings to regulatory authorities around the world by the end of 2022 following completion of the ADvocate studies.

Patients need new treatment options that provide high efficacy and tolerability. These positive data demonstrate that lebrikizumab has the potential to be a leading treatment in AD, said Karl Ziegelbauer, Ph.D., Almirall¡¦s Chief Scientific Officer.

Lilly has exclusive rights for development and commercialization of lebrikizumab in the United States and the rest of the world outside Europe. Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe.

*EASI=Eczema Area and Severity Index, EASI75=75 percent reduction in EASI from baseline to Week 16

www.prnewswire.com/news-releases/majority-of-patients-treated-with-lebrikizumab-achieved-skin-clearance-in-lillys-pivotal-phase-3-atopic-dermatitis-studies-301510964.html
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By - Medical Dialogues Team
Published On 2022-03-20 04:45 GMT | Update On 2022-03-20 04:45 GMT


IQVIA gets CDSCO panel nod to conduct study of ASLAN004 for atopic dermatitis

New Delhi: Drug maker IQVIA has got approval from the Central Drugs Standard Control Organization (CDSCO) to conduct a Phase IIb clinical trial of monoclonal antibody ASLAN004 for triggering symptoms of allergy in atopic dermatitis.This came in line with the protocol presented by the firm for the Phase IIb clinical trial for monoclonal antibody ASLAN004 for triggering symptoms of allergy...
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