歌禮制藥-B(01672.HK):完全自主研發的同類最佳法尼醇X受體激動劑ASC42慢性乙型肝炎II期臨牀試驗完成患者入組
格隆匯3月30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期臨牀試驗患者入組。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。43名慢性乙型肝炎患者已入組3個隊列,分別接受一日一次口服10毫克或15毫克ASC42片或對應的安慰劑,並與恩替卡韋(0.5毫克,口服一日一次)和聚乙二醇干擾素α-2a(180微克,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。與安慰劑隊列相比,10毫克和15毫克ASC42隊列至今安全性和耐受性良好。大部份不良事件(AEs)均為1級或2級,無嚴重不良事件(SAEs)發生。
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毫克、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%。
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