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歌禮制藥-B(01672.HK):ASC10在臨牀試驗中對新型冠狀病毒肺炎的療效可能比莫努匹韋更好
格隆匯 02-07 18:53

格隆匯2月7日丨歌禮制藥-B(01672.HK)發佈公吿,公司的口服雙前藥ASC10及其抗病毒核苷類似物ASC10-A抑制包括奧密克戎在內的多種新型冠狀病毒(SARS-CoV-2)變異株的體內和體外積極數據。

ASC10-A是一款強效的新型冠狀病毒聚合酶(RdRp)抑制劑。ASC10-A對包括奧密克戎在內的多種新型冠狀病毒變異株表現出優異的體外抗病毒活性。儘管奧密克戎變異株攜帶大量突變(包括一個聚合酶內的突變),但是與新型冠狀病毒的野生型或早期變異株相比,ASC10-A對奧密克戎變異株體外抑制活性不減弱。此外,根據猴子中的生物利用度研究,在病人臨牀試驗中治療奧密克戎變異株感染所需要的ASC10-A藥物暴露量是有可能實現的。

ASC10是歌禮完全自主研發的抗病毒核苷類似物ASC10-A的口服雙前藥。口服後雙前藥ASC10主要在腸道被吸收進入血液循環,然後ASC10在血液中快速代謝成為抗病毒核苷類似物ASC10-A。

通過採用雙前藥策略,ASC10在Caco-2細胞(人結直腸腺癌細胞)中的滲透性是莫努匹韋(Molnupiravir)的3.2倍。由於滲透性增加,ASC10在猴子中的口服生物利用度是莫努匹韋(Molnupiravir)的2.3倍。基於猴子和人之間的藥物暴露量關聯關係,預計口服雙前藥ASC10在患者中具有更高的藥物暴露量。因此,ASC10在臨牀試驗中對新型冠狀病毒肺炎的療效可能比莫努匹韋(Molnupiravir)更好。

基於該積極數據,向中國、美國等國家提交臨牀試驗申請的時間可能早於公司原先預期。至今,歌禮已在全球範圍內提交了多項ASC10及其用途的專利申請。

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