歌禮制藥-B(01672.HK):ASC30每日一次口服片在美國Ib期多劑量遞增研究中展現出良好且具差異化的藥代動力學特徵
格隆匯8月28日丨歌禮制藥-B(01672.HK)宣佈,ASC30每日一次口服片在肥胖受試者(體重指數(BMI):30-40 kg/m2)中開展的隨機、雙盲、安慰劑對照的美國Ib期多劑量遞增(MAD)研究(NCT06680440)獲得積極的頂線藥代動力學(PK)數據。在Ib期MAD研究的隊列1(20毫克)和隊列2(40毫克)中,ASC30藥物暴露量(0-24小時藥時曲線下面積AUC0-24h)在穩態下分別達到了3,560 ng.h/mL和5,060 ng.h/mL。這些藥物暴露量數據與安慰劑校準後的相對基線的平均體重下降一致:經28天治療後,隊列1(20毫克)下降4.5%,隊列2(40毫克)下降6.5%,表明更高的藥物暴露量可產生更顯著的減重效果。
“基於目前已公開的臨牀數據,我們相信對於包括orforglipron在內的小分子GLP-1受體(GLP-1R)激動劑而言,更高的藥物暴露量會產生更顯著的減重效果,”歌禮創始人、董事會主席兼首席執行官吳勁梓博士表示,“在非人靈長類動物頭對頭研究中,ASC30藥物暴露量高於orforglipron,這個數據進一步轉化到了人體臨牀研究中。跨試驗對比顯示,ASC30在人體中的藥物暴露量約爲orforglipron的2.3倍至3.3倍,我們對此感到非常激動。鑑於ASC30更高的藥物暴露量在肥胖受試者中產生了更顯著的減重效果,我們相信,與orforglipron相比,ASC30每日一次口服片治療肥胖症具有競爭性及差異化潛力。”
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