歌禮制藥(01672.HK)二期NASH臨牀數據顯示ASC40顯著降低肝臟脂肪含量 應答率高達61%
格隆匯6月17日丨歌禮制藥(01672.HK)公佈，公司的業務夥伴之一Sagimet Biosciences Inc.今日公佈有關口服（每日一次）非酒精性脂肪肝炎(NASH)候選藥物TVB-2640（公司代號：ASC40）的二期(FASCINATE-1)臨牀試驗數據。初步數據顯示TVB-2640顯著降低了肝臟脂肪含量（此試驗的主要療效終點），50mg組別中的應答率為61%。
另外，受試者還表現出肝功能和纖維化指標的改善。公司通過其附屬公司之一，擁有於大中華開發、製造及商業化ASC40(TVB-2640)及相關化合物的獨家許可。連同獨家許可協議，Sagimet完成由公司（通過其附屬公司之一）領投、新投資者和現有投資者跟投的E輪融資並募得2,500萬美元。
在這項隨機、安慰劑對照的二期臨牀研究（FASCINATE-1）中，臨牀研究人員評估了TVB-2640在99名美國NASH患者中的安全性和有效性，每天給藥一次，持續給藥12周。入試者基線滿足肝臟脂肪含量≥8%（由MRI-PDFF測定），且伴有肝纖維化F1-F3。該研究表明，在50mg劑量組中，肝臟脂肪含量相對減少28.2%，而在安慰劑組中，肝臟脂肪含量相對增加4.5%。經過給藥12周後，TVB-2640也顯著降低了谷丙轉氨酶（ALT）達20.4%，降低低密度脂蛋白膽固醇（LDL-cholesterol）達7.6%。這些指標的下降表明肝功能和代謝水平得到改善。
TVB-2640表現出了良好的耐受性，良性不良事件主要為1級事件，無嚴重不良事件發生。在中國開展的50mg劑量臨牀試驗的NASH患者篩選已經開始，擬入組25-30人。
據悉，公司的NASH在研項目中另有兩項在研藥物（自家研發）。ASC41是一款高活性具選擇性的甲狀腺激素β受體（THR-beta）激動劑，其臨牀試驗申請已獲中國國家藥品監督管理局批准。ASC42是一款針對一個不同靶點的IND前NASH候選藥物。該三個NASH候選藥物可單獨或聯合使用。
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