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歐康維視生物-B(01477.HK)在美國啟動OT-301的第二項III期臨牀試驗
格隆匯 11-11 18:10

格隆匯 11 月 11日丨歐康維視生物-B(01477.HK)發佈公告,OT-301(NCX 470)的第二項III期臨牀試驗(即Denali試驗)已由集團的授權合夥人及NCX470的原研人Nicox S.A.(“Nicox”)在美國啟動,美國首位患者於2020年11月9日入組。

公告表示,OT-301(NCX 470)由Nicox與集團正在開發,是同類首創的第二代一氧化氮(NO)供體型貝美前列素類似物,旨在降低開角型青光眼或高眼壓症患者的眼內壓力。

OT-301(NCX 470)的第二項III期臨牀試驗(即Denali試驗)乃為期三個月的III期多區域臨牀試驗,旨在評估OT-301 (NCX 470)滴眼液(0.1%濃度)相比現有標準療法拉坦前列素滴眼液(0.005%濃度)對降低開角型青光眼或高眼壓症患者的眼內壓的安全性及療效。Denali試驗亦包括一項長期安全性擴展試驗,預計將在美國及中國約50個臨牀點對約670名患者隨機進行。Denali試驗旨在達到可在美國及中國提交OT-301(NCX 470)新藥申請的監管規定。Nicox與集團的Denali試驗合作有助試驗較預期提早啟動,並可能加快美國及中國兩地的新藥申請提交審批。隨着Denali試驗的啟動,對OT-301(NCX 470)的聯合開發將進入最後開發階段並保持穩步推進。

OT-301(NCX 470)的首項III期臨牀試驗,即正在進行的Mont Blanc試驗,已於 2020年6月在美國啟動,並於2020年10月獲中國國家藥品監督管理局藥品審評中心批准於中國開展部分Mont Blanc試驗。目前預計Mont Blanc試驗的核心研究結果將於2021年第四季度取得。

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