歌禮制藥-B(01672.HK)：FXR激動劑ASC42治療原發性膽汁性膽管炎的II期臨牀試驗完成首例患者給藥
格隆匯4月10日丨歌禮制藥-B(01672.HK)公佈，公司全資附屬公司甘萊製藥有限公司的ASC42治療原發性膽汁性膽管炎(PBC)的II期臨牀試驗已完成首例患者給藥。
該項II期臨牀試驗（臨牀試驗編號：NCT05190523）由三個ASC42藥物治療組（5mg、10mg和15mg）和一個安慰劑對照組組成，計劃入組100名對熊去氧膽酸(UDCA)應答不佳或不耐受的患者，入組比例為1：1：1：1，療程12周，預計將於2022年底前完成。
2021年11月，中國國家藥品監督管理局批准了210例PBC患者的III期臨牀試驗方案。II期臨牀試驗完成後，甘萊將就相關的藥品註冊事宜（如藥學和毒理學研究）與中國國家藥監局進行溝通，之後隨即啟動III期試驗。
ASC42是一款由公司完全自主研發、擁有全球知識產權、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，未觀察到瘙癢症狀且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%。同時，低密度脂蛋白膽固醇(LDL-C)均值在15mg、每日一次、為期14天的治療期間維持正常水平。
熊去氧膽酸(UDCA)是目前中國唯一獲批的治療PBC的藥物。然而，約40%的PBC患者對UDCA應答不佳或不耐受。奧貝膽酸(OCA)是美國唯一獲批用於治療對UDCA不耐受或應答不佳的PBC患者的藥物，未在中國獲得批准。OCA治療會導致患者的瘙癢症發生率增加，並引起LDL-C水平升高。有效劑量下未出現瘙癢症狀且LDL-C均值維持正常水平使ASC42有望成為同類最佳的PBC候選藥物。甘萊計劃在完成中國II期臨牀試驗後，隨即在中國、美國和歐盟啟動III期臨牀試驗。
2010年中國流行病學研究顯示，中國的PBC患者人數約為65.6萬，其中40歲以上女性患者人數為44萬。美國流行病學研究顯示，2014年，美國的PBC患者人數約為12萬。
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