歌禮制藥-B(01672.HK)：新冠口服RdRp抑制劑ASC10取得積極I期臨牀結果
格隆匯12月12日丨歌禮制藥-B(01672.HK)宣佈，新冠口服聚合酶(RdRp)抑制劑ASC10在健康受試者中的多劑量遞增(MAD)I期研究(NCT05523141)取得積極頂線數據。ASC10是一款創新口服雙前藥，同單前藥莫諾拉韋相比具有新的、差異化的化學結構。口服給藥後，ASC10和莫諾拉韋均可在體內快速、完全轉換為相同的活性藥物ASC10-A，也稱β-D-N4-羥基胞苷(NHC)。雙前藥策略顯著提升了活性藥物ASC10-A的口服生物利用度。
I期數據顯示，所有劑量(包括每次800毫克、每天兩次)的ASC10在中國受試者中安全性及耐受性良好。ASC10治療組和安慰劑治療組的安全性數據相似。雙前藥ASC10在中國受試者中每次800毫克、每天兩次給藥後，活性藥物ASC10-A的暴露量為單前藥莫諾拉韋在日本受試者中每次800毫克、每天兩次給藥後ASC10-A的暴露量的94%。在給藥800毫克後，雙前藥ASC10在中國受試者中的血漿濃度低於檢測下限(0.2納克╱毫升)。同樣地，在給藥800毫克後，單前藥莫諾拉韋在美國受試者中的血漿濃度可以忽略不計。
在體重校正之後，中國受試者給藥800毫克雙前藥ASC10和美國受試者給藥800毫克單前藥莫諾拉韋後的活性藥物ASC10-A的暴露量也是相當的。
食物對ASC10-A暴露量未產生影響，表明ASC10可以隨食物服用，也可空腹服用。
莫諾拉韋已在日本、美國等許多國家獲批或被授權緊急使用。此外，近期文獻顯示莫諾拉韋對奧密克戎感染的中國患者有令人振奮的臨牀療效。
基於歌禮ASC10的I期結果以及莫諾拉韋在美國、日本和中國患者中的臨牀療效數據，ASC10註冊臨牀試驗劑量選定為每次800毫克、每天兩次。
活性藥物ASC10-A對多種奧密克戎變種病毒如BA.5和BA.2.75具有強效的抗病毒活性。歌禮已在全球範圍內提交了多項ASC10及其用途的專利申請。用於該項臨牀研究的ASC10口服片劑是歌禮專有技術開發的產品。
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