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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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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

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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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¨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

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¸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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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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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.

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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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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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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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investors.connectbiopharm.com/events/event-details/global-phase-2b-trial-cbp-201-atopic-dermatitis-data-review-call

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www.morressier.com/o/event/5d4178148fb7e44098e72af1/article/5d4980cb8fb7e44098e72cd2

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