歌禮制藥-B(01672.HK):FXR激動劑ASC42完成乙肝適應症中國橋接試驗,啟動II期臨牀試驗
格隆匯8月25日丨歌禮制藥-B(01672.HK)發佈公吿,其法尼醇X受體(FXR)激動劑ASC42完成慢性乙型肝炎(CHB)適應症中國橋接試驗,並啟動II期臨牀試驗。ASC42是一款由公司完全自主研發、有望成為同類最佳的新型高效選擇性非甾類FXR激動劑。
慢性乙型肝炎是ASC42第二個適應症。作為一款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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