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歌禮制藥-B(01672.HK):FASN抑制劑ASC40在NASH患者II期臨試中國隊列中取得良好頂線數據
格隆匯 03-09 08:04

格隆匯 3 月 9日丨歌禮制藥-B(01672.HK)發佈公吿,公司全資附屬公司甘萊製藥有限公司與Sagimet Biosciences Inc.今日聯合宣佈,脂肪酸合成酶(Fatty Acid Synthase,簡稱FASN)抑制劑ASC40(國外代號為TVB-2640)在隨機、安慰劑對照II期臨牀試驗的中國隊列中取得良好頂線數據(topline results)。口服、每日一次的ASC40有望成為治療非酒精性脂肪性肝炎(NASH)的藥物。初步數據顯示,ASC40顯著降低肝臟脂肪含量(該試驗的主要療效終點),應答率達50% (患者肝臟脂肪含量降低≥30%的比例)。受試者的丙氨酸氨基轉移酶(ALT,一種與炎症相關的肝臟酶)也表現出顯着改善。中國隊列數據與2020年11月發表於美國肝病研究協會(AASLD)肝病會議上的美國隊列數據結果一致。

該II期臨牀試驗中國隊列評估了ASC40片劑在30名非酒精性脂肪性肝炎患者中口服、每日一次50mg、連續給藥12周的安全性和有效性。受試者滿足肝臟脂肪含量 ≥8%(由MRI-PDFF測定)的基線要求,且通過肝臟活檢明確有肝纖維化F1至F3或代謝綜合徵的特徵。該研究顯示,ASC40組肝臟脂肪含量減少28.2%,安慰劑組肝臟脂肪含量減少11.1%。而且,ASC40組患者的丙氨酸氨基轉移酶(ALT)降幅高達29.8%(即12周療程結束時較基線平均下降33U/L),與安慰劑組相比具有顯着的統計學意義(p =0.0499),顯示肝臟炎症程度的降低。63%的ASC40組患者的丙氨酸氨基轉移酶(ALT)下降17U/L或更多,既往研究顯示丙氨酸氨基轉移酶(ALT) 下降17U/L與非酒精性脂肪性肝炎患者肝臟活檢結果改善相關聯。 

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