歌禮制藥-B(01672.HK)完成小分子口服GLP-1R激動劑ASC30美國IIa期研究肥胖或超重受試者入組
格隆匯8月5日丨歌禮制藥-B(01672.HK)公告，董事會宣佈，評估小分子口服GLP-1受體(GLP-1R)激動劑ASC30治療肥胖症的美國13周IIa期研究(NCT07002905)已完成入組。125例受試者均爲肥胖人羣或伴有至少一種體重相關合併症的超重人羣。
"公司很高興宣佈這一重要里程碑，這標誌着ASC30在有望成爲治療肥胖症的獨特差異化療法的道路上又邁進一步。"歌禮創始人、董事會主席兼首席執行官吳勁梓表示，"完成125名受試者入組僅用時一個多月，凸顯了肥胖症市場迫切需要更多治療選擇。公司熱切期待在2025年第四季度獲得這項IIa期研究的頂線數據。作爲一種小分子藥物，如獲批，ASC30有望提供每日一次口服和每月一次皮下注射兩種給藥選擇治療肥胖症。"
這項IIa期研究是一項13周、隨機、雙盲、安慰劑對照和多中心的研究，旨在評估ASC30在肥胖受試者(體重指數(BMI)≥30kg/m2)或伴有至少一種體重相關合併症的超重受試者(27kg/m2≤BMI<30kg/m2)中的療效、安全性和耐受性。試驗評估ASC30的兩種每日一次口服制劑：製劑1(ASC30片)和製劑2(ASC30片A1)。主要終點爲第13周時受試者相對基線的平均體重變化百分比。研究方案中，兩種製劑的起始劑量均下調至1毫克，每週劑量遞增(weeklytitrations)，直至達到製劑1的目標維持劑量20毫克和40毫克，或製劑2的目標維持劑量20毫克、40毫克和60毫克。
兩種製劑均已在ASC30口服Ia期單劑量遞增(SAD)研究(NCT06680440)中進行了評估。製劑2相較製劑1顯示出更平緩的藥代動力學特徵。由歌禮自主研發的ASC30是首款也是唯一一款既可每日一次口服也可每月一次皮下注射的用於治療肥胖症的在研小分子GLP-1R偏向激動劑。
ASC30是一款正在臨牀研究中的小分子GLP-1R偏向激動劑，具有獨特和差異化性質，使得同一小分子同時適用於口服片劑和皮下注射給藥成爲可能。ASC30是一種新化學實體(NCE)，擁有美國和全球化合物專利保護，專利保護期至2044年(不含專利延期)。
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