歌禮制藥(01672.HK)完成ASC18橋接試驗
格隆匯8月20日丨歌禮制藥(01672.HK)公佈,公司已完成ASC18橋接試驗。ASC18是首個由國內生物製藥公司開發的用於治療丙型肝炎的每日口服一次、每次一片的固定劑量複方製劑(FDC)。
ASC18FDC由200毫克拉維達韋(RDV)及400毫克索磷布韋(SOF)組成。ASC18I期橋接試驗為隨機、雙臂(即ASC18FDC片劑及(200毫克RDV+400毫克SOF單方製劑聯合給藥))、兩週期、兩階段(單次給藥階段和多次給藥階段)、兩序列交叉設計。20名受試者的橋接試驗結果表明,ASC18FDC片劑具有與200毫克RDV+400毫克SOF單方製劑聯合給藥相似的藥代動力學特性、安全性及耐受性。
由Drugsfor Neglected Diseasesinitiative (DNDi)開展並於2018年4月12日在巴黎舉行的國際肝病大會上展示的一項代號為STORM-C-1的II/III期試驗,入組有300位HCV患者,給藥方式為200mg RDV+400mgSOF單方製劑聯合給藥,非肝硬化患者療程12周,代償期肝硬化患者療程24周。結果顯示整體治癒率(持續病毒學應答率,SVR12)為97%,肝硬化患者的治癒率(SVR12)為96%,被試驗的基因類型具有較高治癒率(SVR12):基因1a型的為99%,基因1b型的為100%,基因3a型的為96%,基因3b型的為100%,以及基因6型患者(入組人數較少)的為81%。對於HCV/HIV合併感染患者的治癒率(SVR12)為97%;基因3型患者的整體治癒率(SVR12)為97%,其中合併代償期肝硬化患者的治癒率(SVR12)為96%。
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