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歌禮制藥-B(01672.HK)完成ASC42慢性乙型肝炎(CHB)適應症II期臨牀試驗首例患者給藥
格隆匯 01-11 08:05

格隆匯1月11日丨歌禮制藥-B(01672.HK)發佈公吿,公司已完成ASC42慢性乙型肝炎(CHB)適應症的II期臨牀試驗首例患者給藥。

根據披露,該II期臨牀試驗(臨牀試驗編號:NCT05107778)是一項多中心、隨機、單盲、安慰劑對照的中國臨牀試驗,以評估ASC42片與恩替卡韋和聚乙二醇干擾素α-2a聯用在慢性乙型肝炎患者中的安全性和有效性。約45名慢性乙型肝炎患者將入組並接受一日一次口服ASC42片(10 mg或15 mg)或安慰劑,並與恩替卡韋(0.5 mg,口服一日一次)和聚乙二醇干擾素α-2a(180 μg,皮下注射一週一次)聯合治療12周,在12周治療期和24周隨訪期內,檢測血清乙肝表面抗原(HBsAg)和乙肝病毒(HBV)前基因組RNA (pgRNA)相較基線的變化。

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法尼醇X受體(FXR)激動劑。ASC42美國I期臨牀試驗(臨牀試驗編號:NCT04679129)表明,在人體有效劑量15 mg、一日一次、為期14天的治療過程中,未觀察到瘙癢症狀,且低密度脂蛋白膽固醇(LDL-C)維持正常水平。同時,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天時的增幅高達1,780%,7α-羥基-4-膽甾烯-3-酮(C4)在給藥第14天時的降幅高達91%。

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具有顯著的抑制作用,表明ASC42有望實現慢性乙型肝炎功能性治癒。

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