歌禮制藥-B(01672.HK):ASC09/利托那韋複方片獲新藥臨牀試驗(IND)批准
格隆匯4月13日丨歌禮制藥-B(01672.HK)公佈,公司已就其人類免疫缺陷病毒(HIV)蛋白酶抑制劑ASC09/利托那韋複方片(ASC09F)獲得國家藥品監督管理局的新藥臨牀試驗(IND)批准。ASC09F的新藥臨牀試驗(IND)申請於2019年12月30日獲得國家藥監局受理。
ASC09具有極高的基因耐藥屏障,已經完成的I期及IIa期臨牀試驗顯示,ASC09具有有效抗病毒活性。過往的臨牀試驗亦顯示ASC09安全且耐受性良好。使用ASC09單一治療兩週後,病毒載量降低1.79log(患者血液樣本中病毒載量降低62倍);研究顯示,HIV對ASC09產生耐藥性之前需要七次突變,表明相較與其他已批准的蛋白酶抑制劑,ASC09對耐藥性具有更高的基因屏障,這些特點令ASC09成為初治及復治患者HIV療法的優選藥物。ASC09於2013年獲得Janssen R&D Ireland許可(TMC310911)在大中華地區進行研發和商業化,有可能成為治療HIV-1型感染的同類最佳蛋白酶抑制劑。
利托那韋不僅是一種HIV蛋白酶抑制劑,也是一種強效CYP3A4抑制劑。臨牀試驗表明,小劑量的利托那韋可抑制CYP3A4介導的HIV蛋白酶抑制劑的代謝,從而提高HIV蛋白酶抑制劑的血藥濃度,增強抗病毒藥物療效。
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