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歌禮制藥-B(01672.HK):FXR激動劑ASC42慢性乙肝適應症中國橋接試驗完成首個健康受試者隊列給藥
格隆匯 07-13 08:07

格隆匯7月13日丨歌禮制藥-B(01672.HK)發佈公吿,2021年6月7日,公司宣佈中國國家藥品監督管理局已批准ASC42開展用於治療慢性乙型肝炎的臨牀試驗申請。

2021年6月16日,公司宣佈其全資附屬公司甘萊製藥有限公司的ASC42在用於治療非酒精性脂肪性肝炎的美國I期臨牀試驗中取得良好的安全性和藥效學生物標誌物頂線數據。數據顯示在為期14天、每日一次、每次15mg的治療過程中,未觀察到瘙癢症狀或治療引起的丙氨酸氨基轉移酶(ALT)和天門冬氨酸氨基轉移酶 (AST)升高。

基於美國ASC42 I期臨牀試驗64名健康受試者的藥代動力學數據,中國橋接試驗為一項隨機、安慰劑對照、雙盲的單劑量遞增研究(5mg和15mg)。共30名健康受試者接受ASC42或安慰劑治療(臨牀試驗註冊編號:NCT04679129)。該項橋接試驗旨在確定即將在中國開展的II期臨牀試驗慢性乙型肝炎患者的劑量選擇。

作為FXR激動劑,ASC42對乙肝病毒(HBV)具有獨特的作用機制:ASC42可抑制HBV cccDNA轉錄為HBV RNA,進而抑制HBV RNA翻譯為HBsAg。同時, ASC42可能會降低HBV cccDNA的穩定性。體外人原代肝細胞(PHH)研究和小鼠腺相關病毒介導的乙肝病毒(AAV-HBV)感染研究均顯示,ASC42對HBsAg和 HBV pgRNA具有顯着的抑制作用,表明ASC42有望實現慢性乙型肝炎功能性治癒。

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