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------- ASLAN004-¨È·à±d 2014¦~ ¨È·à±d©MCSL ñ¬ù¦@¦P¶}µo°µ§¹·§©À©ÊÁ{§É«á¦A±ÂÅv ¥þ²y°Ó·~¤Æ,§Q¼í§¡¤À. 2019/05/31 ¨È·à±d ñ¤U¥þ²y°Ó·~¤Æ,·s¦X¬ù±ø¥ó¦p¤U: ¨È·à±d-KY ±N©ó ASLAN004 ¤T´Á¸ÕÅç±Ò°Ê®É¤ä¥I CSL ºµ§´Ú¶µ 3,000 ¸U¬üª÷¡C CSL ±N¥i¦¬¨ú³Ì°ª¹F 9,500 ¸U¬üª÷¤§¥Ó½Ð¶i«×¨½µ{ª÷¡B ³Ì°ª¹F 6.55 »õ¤§¾P°â¨½µ{ª÷¥H¤Î¨Ì¾P°â²bÃB¤À¼h¦¬¨úÓ¦ì¼Æ¤¤¦ì¼Æ¦Ü 10%¤§Åv§Qª÷¡C
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------- ASLAN004-¨È·à±d 2014¦~ ¨È·à±d©MCSL ñ¬ù¦@¦P¶}µo°µ§¹·§©À©ÊÁ{§É«á¦A±ÂÅv ¥þ²y°Ó·~¤Æ,§Q¼í§¡¤À. 2019/05/31 ¨È·à±d ñ¤U¥þ²y°Ó·~¤Æ,·s¦X¬ù±ø¥ó¦p¤U: ¨È·à±d-KY ±N©ó ASLAN004 ¤T´Á¸ÕÅç±Ò°Ê®É¤ä¥I CSL ºµ§´Ú¶µ 3,000 ¸U¬üª÷¡C CSL ±N¥i¦¬¨ú³Ì°ª¹F 9,500 ¸U¬üª÷¤§¥Ó½Ð¶i«×¨½µ{ª÷¡B ³Ì°ª¹F 6.55 »õ¤§¾P°â¨½µ{ª÷¥H¤Î ¨Ì¾P°â²bÃB¤À¼h¦¬¨úÓ¦ì¼Æ¤¤¦ì¼Æ¦Ü 10%¤§Åv§Qª÷¡C
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------- ASLAN004-¨È·à±d 2014¦~ ¨È·à±d©MCSL ñ¬ù¦@¦P¶}µo°µ§¹·§©À©ÊÁ{§É«á¦A±ÂÅv ¥þ²y°Ó·~¤Æ,§Q¼í§¡¤À. 2019/05/31 ¨È·à±d ñ¤U¥þ²y°Ó·~¤Æ,·s¦X¬ù±ø¥ó¦p¤U: ¨È·à±d-KY ±N©ó ASLAN004 ¤T´Á¸ÕÅç±Ò°Ê®É¤ä¥I CSL ºµ§´Ú¶µ 3,000 ¸U¬üª÷¡C CSL ±N¥i¦¬¨ú³Ì°ª¹F 9,500 ¸U¬üª÷¤§¥Ó½Ð¶i«×¨½µ{ª÷¡B ³Ì°ª¹F 6.55 »õ¤§¾P°â¨½µ{ª÷¥H¤Î ¨Ì¾P°â²bÃB¤À¼h¦¬¨úÓ¦ì¼Æ¤¤¦ì¼Æ¦Ü 10%¤§Åv§Qª÷¡C ------------------- p¹º2022¦~°µ§¹2b ´ÁADÁ{§É¦A±ÂÅv .
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ASLAN004 ¼È®ÉÀu©ó Dupilumab 2a ,n=118¤H , 300mg/¨C¶g¤@°w(°_©l¶q600mg),ªº¥§¡EASI°´T ²Ä¥|¶gEASI ¥§¡°´T¬ù61% ²Ä¤¶gEASI ¥§¡°´T¬ù67% ²Ä¤»¶gEASI ¥§¡°´T¬ù70% ²Ä4-6¶g¥§¡°´T¬ù67% ¹Ï¤@¥Øµø
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www.nejm.org/doi/full/10.1056/NEJMoa1610020?cookieSet=1
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2. 丅ralokinumab , 2019¦~¦~©³¡A¤T´ÁÁ{§É¹LÃö¡B¥«³õ¤ÀªR®v¹w´ú2027¦~¥i¾P°â16»õ¬ü¤¸¡A¸Ó¤½¥qLEO 2016 ±ÂÅv¦Û¤W´åªü´µ§Q±d¡]LSE¡GAZN¡^¼t°Ó11.5»õ¬ü¤¸¡C ¥t©ó2020¦~¥|¤ë ñ¤U¦X¤@FB825 5.3»õ¬ü¤¸ªº±ÂÅv¡C
¹vÂI : IL13 °tÅéADÃì¡A300mg/¨C¤G¶g¤@°w.
Tralokinumab 2~2.9/¹ï·Ó²Õ 1= 2.2~2.9 , P=0.002~ <0.001¡]2Ó¤T´ÁÁ{§É«ü¼ÐIGA 0/1 ¡AEASI-75) IGA0/1 15.8%~22.2%/7.1%~10.9% =2.2~2 EASI-75 25%~33.2%/12.7%~11.4%=2~2.9
www.practiceupdate.com/content/aad-2020-tralokinumab-with-and-without-topical-corticosteroids-effective-in-moderate-to-severe-atopic-dermatitis/102983/45
3. Lebrikizumab ,2019¦~10¤ë¡A¶}©l¤T´ÁÁ{§É,¸Ó¤½¥qDermira 2020¦~³Q ¬ü°ê§¨ÓÃļt11»õ¬ü¤¸¨ÖÁÊ¡C ¹vÂI : IL13°tÅéBCÃì¡A250mg/¨C¶g¤G°w¡A
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IGA0/1 Lebrikizumab 44.6%/ ¹ï·Ó²Õ15.3%=2.9
EASI-90 Lebrikizumab 44.7%/ ¹ï·Ó²Õ11.4.%=3.9
www.businesswire.com/news/home/20191017005896/en/Dermira-Presents-Data-Phase-2b-Study-Lebrikizumab
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ASLAN004 ¼È®ÉÀu©ó Dupilumab 2a ,n=118¤H , 300mg/¨C¶g¤@°w(°_©l¶q600mg),ªº¥§¡EASI°´T ²Ä¥|¶gEASI ¥§¡°´T¬ù61% ²Ä¤¶gEASI ¥§¡°´T¬ù67% ²Ä¤»¶gEASI ¥§¡°´T¬ù70% ²Ä4-6¶g¥§¡°´T¬ù67% ¹Ï¤@¥Øµø
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Tralokinumab 2bÁ{§É ¹w«á«ü¼Ð,¥»¤ñDupilumab 2b ®t ---------------------------------------------- Phase 2b-Dupilumab-300mg/q2w/12 weeks ,n=64 (Table) 1.EASI-50 81.3%(52/64=81.3%) 2.EASI-75 54.3%(35/64=54.3%) 3.EASI-90 29.7%(19/64=29.7%) 4.IGA 0/1 25%(16/64=25%)
phase2 -placebo-300mg/q2w/12 weeks n=61 1.EASI-50 29.5%(18/61=29.5%) 2.EASI-75 13.1%(8/61=13.1%) 3.EASI-90 3.3%(2/61=3.3%) 4.IGA 0/1 0%(0/61=0%)
p=0.001
journals.lww.com/jaanp/Fulltext/2018/09000/Efficacy_and_safety_of_dupilumab_for_the_treatment.10.aspx
Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults
A pooled analysis of two phase 2 clinical trials
------------------------------ Tralokinumab 2bÁ{§É, 300mg/2¶g¤@°w¡A12¶g
¤G´ÁÁ{§Éµ²ªG www.ncbi.nlm.nih.gov/m/pubmed/29906525/
n=51:51,Á{§Éµ²ªG¡A
(1)IGA 26.7%¹êÅç²Õ;vs 11.8%¹ï·Ó²Õ;¡Cp¦ô=0.046
(2)EASI¥§¡¤À¼Æ®t²§ ¹êÅç²Õ;-¹ï·Ó²Õ; 4.94 ,p =0.01
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(¤@).250 mg Q2W(¨â¶g¤@°w) EASI-50 81.0%*** EASI-75 60.6%*** EASI-90 44.0%*** IGA0/1 44.6%**
(¤G).250 mg Q4W(¥|¶g¤@°w) EASI-50 77.0%** EASI-75 56.1%** EASI-90 36.1%** IGA0/1 33.7%*
(¤T)¹ï·Ó²ÕPlacebo
EASI-50 45.8% EASI-75 24.3% EASI-90 11.4% IGA0/1 15.3% |
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LEOªºtralokinumab ¤T´ÁÁ{§É«ü¼Ð IGA¡A0/1¡A©M¹ï·Ó组¤ñ¤j约2:1 ¦ÓDupilumab ¤T´Á¦P«ü¼Ð3.8/4:1, ¥i¨£¦p¤½¥q©Ò»¡¡A§@¥Î¦bIL13ªº°tÅéA¡BDÃ줣¦pIL4¨üÅé¡C
Ãø©ÇLEO¡A«æ§ä¦X¤@FB825±ÂÅv¡A¨Ó¸É®t²§¡C
Á`¤§tralokinumab¤£¬ODupilumabªº¹ï¤â¡C
Significantly greater IGA 0/1 and EASI 75 response rates at week 16 were observed with tralokinumab with and without topical corticosteroids, when compared with placebo. In ECZTRA 1, 15.8% of patients taking tralokinumab had an IGA 0/1, compared with 7.1% on placebo (P = .002), and 25.0% had an EASI 75 versus 12.7% with placebo (P < .001). In ECZTRA 2, the IGA 0/1 proportion was 22.2% versus 10.9% (P < .001), and EASI 75 proportion was 33.2% versus 11.4% (P < .001). For ECZTRA 3, the respective proportions were 38.9% versus 26.2% (P = .015) for IGA 0/1 and 68.0% versus 36.7% (P < .001) for EASI 75.
For the ECZTRA 1 and 2 trials, a sensitivity analysis of nonresponders demonstrated superior outcomes among those on active therapy even in this group. Specifically, the proportion with an IGA 0/1 was 19.1% with active therapy versus 8.1% with placebo (P < .001) in ECZTRA 1 and 24.0% versus 12.4% (P < .001) in ECZTRA 2. For EASI 75, the respective proportions were 33.4% versus 17.3% (P< .01) and 37.9% versus 16.4% (P < .01).
Following the maintenance treatment period, the use of tralokinumab with and without topical corticosteroids successfully preserved IGA 0/1 and EASI 75. At 52 weeks, among responders who received tralokinumab every 2 weeks during maintenance, 51.3% had an IGA 0/1 and 59.6% had an EASI 75 in ECZTRA 1. For ECZTRA 2, the respective values were 59.3% and 55.8%. At week 32 in ECZTRA 3, 89.6% of responders receiving tralokinumab every 2 weeks during maintenance had an IGA 0/1 and 92.5% EASI 75. These response rates were only significantly greater than placebo in ECZTRA 2, however. |
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to develop a comprehensive conversion plan, by which the Company would facilitate the ability of itsshareholders, at their option, to convert its ordinary shares into ADSs listed on Nasdaq over a 6-12 month time frame.
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Board of Directors¡¦ Meeting to consider next steps after advice from Taipei Exchange (¡§TPEx¡¨) on possible delisting of ASLAN Pharmaceuticals Limited from TPEx As previously reported on Form 6-K dated June 9, 2020, ASLAN Pharmaceuticals Limited (the ¡§Company¡¨) disclosed that as a result of irregular trading of its ordinary shares, TPEx had requested the Company publish certain regulatory and financial information on TPEx¡¦s Market Observation Post System (¡§MOPS¡¨). Such MOPS notice identified that as a result of the Company¡¦s anticipated negative net worth and lack of operating revenue for the six months ending June 30, 2020, the Company anticipated that TPEx would delist the Company¡¦s ordinary shares from trading on TPEx (the ¡§TPEx Delisting¡¨). As previously reported, the Company also confirmed that in the event of the TPEx Delisting, the listing of the Company¡¦s ADSs on the Nasdaq Global Market (¡§Nasdaq¡¨) in the United States would be unaffected, and ADS would continue to trade on Nasdaq. On June 15, 2020, the Company announced that the Board of Directors of the Company (the ¡§Board¡¨) held a meeting to discuss the potential impact of a TPEx Delisting. Among other things, the Board confirmed that in order to help achieve and preserve value for its shareholders if a TPEx Delisting occurs, it was authorizing and directing the Company to develop a comprehensive conversion plan, by which the Company would facilitate the ability of its shareholders, at their option, to convert its ordinary shares into ADSs listed on Nasdaq over a 6-12 month time frame. The Company intends to update its shareholders as to details of such plan once formalized and approved by the Board. The Company also confirmed that a TPEx Delisting would have the effect that all Taiwan and TPEx laws, regulations and rules regarding its securities would cease to apply to the Company. It was noted by the Board that this change could potentially benefit the Company¡¦s ability to raise capital through the sale of its securities in ways that are currently prohibited or not feasible under TPEx rules and Taiwanese laws. Forward-looking statements This Form 6-K contains forward-looking |
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