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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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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 ¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1¶ ·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2022/5/7 ¤U¤È 06:55:17²Ä 176 ½g¦^À³ Humira ªº²Ä¤@ӥͪ«¬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).
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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. ¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1¶ ·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2022/5/7 ¤W¤È 10:32:37²Ä 175 ½g¦^À³ Herceptin ¶PÀù¥ 1999¦~FDA ®Öã¤W¥«,
2019¦~¬ü°ê ²Ä¤@ÓHerceptin ¶PÀù¥¬Û¦üÃľP°â.
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www.genetinfo.com/investment/featured/item/7060.html
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Hurmira FDA 2002¦~12¤ë31¤é®Öã¤W¥« ¬ü°ê¤W¥«±M§Q12¦~¡A2014¦~12¤ë31¤é¨ìÃÄ¡C ¬ü°ê销°â¦û80%,¦~¾P¦Ê»õ¡C 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 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
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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
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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 84Ó¦¬®×¤¤¤ß// ¦¬380¤H//5²Õ |
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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 sec.report/Document/0001193125-22-138757/
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
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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-307ȱo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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¹ï·Ó²Õ/¤G¶g¤@°wQ2w/¤@¶g¤@°wQ1w 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
¹ï·Ó²Õ/¤G¶g¤@°wQ2w/¤@¶g¤@°wQ1w 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)
------------------------- §CIgE VS °ªIgE(Q2W)
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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
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ASLN è褽¥¬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. Google ½Ķ ¹wp§Y±N¨ì¨Óªº¨½µ{¸O
p¹º©ó 2022 ¦~¤W¥b¦~±Ò°Ê farudodstat¡]¤]ºÙ¬° ASLAN003¡^¦bª¢¯g©Ê¸z¯f¤¤ªº 2 ´Á¬ã¨s¡C
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eblasakimab 2b ´Á TREK-AD ¬ã¨sªº¤@½u¼Æ¾Ú¹wp±N¦b 2023 ¦~¤W¥b¦~µo¥¬¡C |
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ir.aslanpharma.com/static-files/ceada264-1ef5-41f8-bb3f-d9f433510cdb
ASLN ³Ì¤jªÑªF,«ùªÑ5.4% ----2022¦~4¤ë21¤é----(2021/09/27¸Ñª¼«á,³s¶R3©u,2021/Q1 ¦A¥[¶R¬ù1700¤dªÑADR,²Öp3,759¤dªÑADR)
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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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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§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§Ú̪º 2b ´Á¸ÕÅç¼Æ¾ÚÅã¥Ü§Ú̪º 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§Ú̪ºÁ{§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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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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Y²Ä¤T²Õ¸ÕÅçExperimental: ASLAN004 400 mg every four weeks (q4w) 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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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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¥»¤½¥q¦³ 180 Ó¤é¾ä¤é©Î 2022 ¦~ 9 ¤ë 26 ¤éªº´Á¨Ó«·s¿í¦u¤W¥«³W«h¡C¬°« ·s¿í¦u¤W¥«³W«h¡A¥»¤½¥q¬ü°ê¦s°UªÑªº¦¬½L»ù¥²¶·¦Ü¤Ö³sÄò¤QÓ¤u§@¤é¹F¨ì©Î¶W¹L ¨CªÑ¬ü°ê¦s°UªÑ 1.00 ¬ü¤¸¡C¦pªG¤½¥q¦b 2022 ¦~ 9 ¤ë 26 ¤é¤§«e¥¼¯à«ì´_¦X ³W¡A¤½¥q¥i¯à¦³¸ê®æ¦bÃB¥~ªº 180 Ó¤é¾ä¤é¤º«ì´_¦X³W¡A§_«h¥i¯à±Á{°h¥«¡C 2022¦~9¤ë26¤é¦A¥[180¤Ñ´N¨ì2023¦~3¤ë¤F¡A ASLAN004¦~©³ªº´Á¤¤³ø§iÅåÆA¡AªÑ»ù´N·|¦^¨ì¨CªÑ¬ü°ê¦s°UªÑ 1.00 ¬ü¤¸¥H¤W¡A ASLAN004¦~©³ªº´Á¤¤³ø§iY±¼º£¡A´N¤£¥Îµ¥¸Ñª¼¤F¡K¡K ©Ò¥HªÑ»ù¤£·|¼vÅT¨È·à±dªº¬ã¨s¶i«× ¬Û¤Ïªº¡A¨È·à±dªº¬ã¨s¶i«×·|¼vÅTªÑ»ù¡C
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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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ASLAN004 ¤¤-««×AD 2b Á{§É¼W¥[¤@Ó·s¥[©Yªº¦¬®×¤¤¤ß¡A²Öp20Ó¦¬®×¤¤¤ß¡C ¡K¡K¬ü¡B¿D¡B纽¡B·s¡C
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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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-------//CNTB CBP201ªº¦Û§Ú¤ÀªR,¤@¼Ë没Á׶}°ò½u§CTRACT/§CEASI,·Ó¦¨Àø®Ä§C¸¨,¥§¡°´TEASI53%//DUPILUMAB ¤T´Á¥§¡°EASI78%.
§Æ±æ¤j®a§Ö¼gE-MAIL µ¹ASLN ,½Ð¥LÌ¿í´`DUPILUMAB 2b Á׶} °ò½uEASI<21/§CTRAC²Õ, ©Ô°ª¨ì°ò½u¥§¡EASI25/§CTRAC²Õ .
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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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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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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IQVIA gets CDSCO panel nod to conduct study of ASLAN004 for atopic dermatitis
Subscribe to Notifications 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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Out-License and Other Agreements Almirall Agreement
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¥»¤½¥q§¹¥þ¦³·N¸Ñ¨M¸Ó¯Ê³´¨Ã«·s¿í¦u¤W¥«³W«h ASLAN PHARMACEUTICALS LIMITED MENLO PARK, Calif. and SINGAPORE, April 01, 2022 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (NASDAQ: ASLN) (ASLAN or the Company), announced today that on March 28, 2022, it received a written notice (the Notice) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (Nasdaq) indicating that the Company is not in compliance with the US$1.00 minimum bid price requirement under the Nasdaq Listing Rules (the Listing Rules). Based on the closing bid price of the Company¡¦s listed securities for the last 30 consecutive business days from February 11, 2022 to March 25, 2022, the Company has not met the minimum bid price requirement set forth in Listing Rule 5550(a)(2) during that period. The Notice is only a notification of deficiency and has no immediate effect on the listing of the Company¡¦s American Depositary Shares (¡§ADS¡¨). The Company¡¦s ADSs will continue to trade on the Nasdaq Global Market at this time. The Company¡¦s receipt of the Notice does not impact the Company¡¦s business, operations or reporting requirements with the Securities and Exchange Commission.
The Notice states that under Listing Rule 5810(c)(3)(A) the Company is provided with a period of 180 calendar days, or September 26, 2022, to regain compliance with the Listing Rules. To regain compliance with the Listing Rules, the closing bid price of the Company¡¦s ADSs must meet or exceed US$1.00 per ADS for at least ten consecutive business days. In the event the Company does not regain compliance by September 26, 2022, the Company may be eligible for an additional 180 calendar day period to regain compliance or may face delisting.
The Company intends to continue to monitor the closing bid price of its ADSs between now and September 26, 2022, and to evaluate its available options to regain compliance.
The Company fully intends to resolve the deficiency and regain compliance with the Listing Rules.
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Name of Beneficial Owner Number of Ordinary Shares Beneficially Owned Equivalent Number of ADSs beneficially owned Percentage of Shares Beneficially Owned Executive Officers and Directors:
Carl Firth, Ph.D.(1) 8,904,686 1,780,937 1.9% Kiran Asarpota(2) 1,649,721 329,944 * Ben Goodger(3) 1,441,850 288,370 * Kenneth Kobayashi(4) 1,550,775 310,155 * Stephen Doyle(5) 1,095,830 219,166 * Robert E. Hoffman(6) 306,250 61,250 * Andrew Howden(7) 1,215,565 243,113 * Neil Graham(8) 101,565 20,313 Kathleen Metters(9) 93,750 18,750 All current executive officers and directors
as a group (9 persons)(10) 16,359,991 3,271,998 4.69%
ASLN 9 ¦ì¸³¨Æ¤Î°ª¶¥¥DºÞ «ù蓸³qªÑ 16,359,991 «ùADR 3,271,998 ¦û¤½¥q«ùªÑ¤ñ4.69%
2022/01/24 As of January 24, 2022, to the best of our knowledge, approximately 337,297,360 ordinary share
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Top Institutional Holders finance.yahoo.com/quote/ASLN/holders?p=ASLN
Holder Shares Date Reported ADR RTW Investments LP 3,250,000 Dec 30, 2021 Vivo Capital, LLC 2,840,909 Dec 30, 2021 Citadel Advisors Llc 2,717,907 Dec 30, 2021 Mangrove Partners 2,514,576 Dec 30, 2021 Tang Capital Management, LLC 2,054,925 Dec 30, 2021 Orbimed Advisors LLC. 1,970,000 Dec 30, 2021 Temasek Holdings (Private) Limited 1,678,075 Dec 30, 2021 Millennium Management LLC 1,619,125 Dec 30, 2021 SilverArc Capital Management, LLC 1,498,192 Dec 30, 2021 Sio Capital Management, LLC 1,270,758 Dec 30, 2021
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300 mg/2 mL Dupixent subcutaneous solution from $3,487.62 for 4 milliliters Quantity Per unit Price 4 (2 x 2 milliliters) $871.91 $3,487.62
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MarketBeat ASLAN Pharmaceuticals (NASDAQ:ASLN) Rating Lowered to Sell at Zacks Investment Research The company¡¦s product portfolio includes Varlitinib, ASLAN004, ASLAN002 and ASLAN003 both are in clinical stage. ASLAN Pharmaceuticals Limited... |
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