歌禮制藥-B(01672.HK):FXR激動劑ASC42治療原發性膽汁性膽管炎的藥物-藥物相互作用研究在美國完成首例受試者給藥
格隆匯8月16日丨歌禮制藥-B(01672.HK)發佈公吿,公司全資附屬公司甘萊製藥有限公司的候選藥物法尼醇X受體(FXR)激動劑ASC42用於治療原發性膽汁性膽管炎(PBC)的藥物-藥物相互作用(DDI)研究在美國完成首例受試者給藥。該項DDI研究預計於2022年8月在美國共入組12名受試者並於2022年第4季度初完成。該項DDI研究以及正在中國進行的II期PBC患者的臨牀試驗將為後續於中國、美國和歐盟開展治療PBC的III期臨牀試驗提供更多支持。
PBC是一種慢性進展性自身免疫性膽汁淤積性疾病,常發展為肝纖維化及肝硬化,直至需進行肝移植或導致死亡。為應對日益增長的發病率,亞太肝臟研究協會(Asian Pacific Association for the Study of the Liver, APASL)於2022年發佈了 PBC患者診斷及管理臨牀實踐指南。全球範圍內PBC的發病率和患病率均呈現上漲趨勢,該疾病正受到廣泛的關注。
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