歌禮制藥-B(01672.HK)在美國遞交口服抗病毒藥物ASC10的猴痘適應症新藥臨牀試驗申請
格隆匯10月26日丨歌禮制藥-B(01672.HK)公吿,已向美國食品藥品監督管理局(FDA)遞交針對猴痘病毒聚合酶的口服抑制劑候選藥物ASC10的新藥臨牀試驗(IND)申請。
ASC10是一款口服且廣譜抗病毒的雙前藥,同單前藥莫努匹韋(molnupiravir)相比具有新的差異化的化學結構。口服給藥後,ASC10和莫努匹韋均可在體內快速、完全轉換為相同的活性代謝物ASC10-A,也稱β-D-N4-羥基胞苷(NHC)或EIDD-1931。歌禮已在全球範圍內提交多項ASC10及其治療病毒性疾病用途的專利申請,包括治療猴痘病毒感染。
體外猴痘病毒感染細胞模型中的實驗數據顯示,ASC10-A對猴痘病毒具有強效的抗病毒活性,表明ASC10有望成為猴痘病毒感染的有效療法。該研究由歌禮委託IIT研究所實施,該研究所總部位於美國芝加哥市伊利諾伊理工學院。
2022年8月,日本東京的國立傳染病研究所的Watashi博士等人發表了一篇研究論文。Watashi博士等人在該研究中共測試了132種藥物,結果顯示莫努匹韋(活性代謝物ASC10-A)以及另兩種藥物在猴痘病毒感染細胞模型中具有強效的抗病毒活性。其餘129種藥物如瑞德西韋、法匹拉韋、索磷布韋和利巴韋林等均無抗猴痘病毒活性。
通過採用雙前藥策略,ASC10在Caco-2細胞(人結直腸腺癌細胞)中的滲透性和在猴子中的活性代謝物暴露量分別達到了莫努匹韋的3.2倍和2.1倍。研究表明,ASC10-A對多種奧密克戎變種病毒(BA.1EC50=0.3μM;BA.2EC50=0.25μM;BA.5EC50=0.23μM;BA.2.75EC50=0.90μM)具有強效的細胞抗病毒活性。目前該項在新冠患者中開展的Ib期臨牀試驗正在美國有序進行。
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