歌禮制藥-B(01672.HK)：同類第一雙靶點固定劑量複方製劑ASC43F用於治療非酒精性脂肪性肝炎的美國臨牀試驗申請獲批
格隆匯11月1日丨歌禮制藥-B(01672.HK)發佈公吿，公司全資附屬公司甘萊的在研管線藥物ASC43F獲美國食品藥品監督管理局(FDA)批准開展臨牀試驗，並啟動全球開發計劃。ASC43F是一種用於治療非酒精性脂肪性肝炎(NASH)的同類第一、針對甲狀腺激素β受體(THRβ)和法尼醇X受體(FXR)雙靶點的固定劑量複方製劑(FDC)。
根據披露，ASC43F是一種每日服用一次、由ASC41和ASC42組成的固定劑量單片複方製劑。ASC41是一款處於全球臨牀開發階段的口服肝臟靶向性THRβ激動劑前體藥物，此前在中美進行的I期臨牀研究顯示，ASC41具有良好的耐受性，並在低密度脂蛋白膽固醇(LDL-C)升高的超重和肥胖受試者(具有非酒精性脂肪性肝炎特徵的人羣)中顯著降低低密度脂蛋白膽固醇、甘油三酯(TG)和總膽固醇(TC)。ASC42是一款處於全球臨牀開發階段的新型高效選擇性非甾類FXR激動劑，I期臨牀試驗數據顯示，在人體有效劑量15mg、每日一次、為期14天的治療過程中，未觀察到瘙癢症狀，FXR靶向激活的生物標誌物成纖維細胞生長因子19(FGF19)在給藥第14天(每日一次、每次15mg)時的增幅高達1,780%，FXR靶向激活的生物標誌物7α-羥基-4-膽甾烯-3-酮(C4)在給藥第14天(每日一次、每次15mg)時的降幅高達91%。
此次美國IND獲批是基於在大鼠NASH模型中ASC41和ASC42聯合用藥後的療效數據，該聯合療法顯示出對血清甘油三酯和肝臟總膽固醇、炎症、氣球樣變、非酒精性脂肪性肝病(NAFLD)活動評分(NAS)和纖維化的顯著改善。同時，根據即將在美國肝病研究協會年會上報吿的研究數據，來源於ASC43F片的ASC42和ASC41A(ASC41的活性代謝產物)在犬體內的藥代動力學參數與ASC42和ASC41單片保持一致。
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