歐康維視生物-B(01477.HK):OT-301(NCX470)在中國獲批III期臨牀試驗
格隆匯 10 月 23日丨歐康維視生物-B(01477.HK)公告,作為集團產品管線一的OT-301(NCX470)日前獲中華人民共和國("中國")國家藥品監督管理局藥品審評中心批准,在中國開展公司計劃的兩項III期臨牀試驗的其中一項。OT-301(NCX470)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及高眼壓症患者的眼內壓力("眼內壓")。
與拉坦前列素滴眼液(0.005%濃度,在中國用於青光眼及高眼壓症的最廣泛的一線處方治療藥物)相比,OT-301(NCX470)滴眼液(0.065%濃度)在其II期臨牀試驗中表現出更好的降低眼內壓的治療效果。透過在貝美前列素(被認為是迄今為止獲批的最有效前列腺素類似物)中添加一氧化氮介導功效,OT-301(NCX470)有望成為降低青光眼及高眼壓症患者眼內壓的潛在同類最佳治療藥物。
此乃公司首次獲批於中國開展的國際多中心III期臨牀試驗。公司與其授權合夥人NicoxS.A.("Nicox",NCX470的發起人)擬於取得監管機構批准後在美國及中國就OT-301(NCX470)開展兩項國際多中心III期臨牀試驗,旨在評估OT-301(NCX470)滴眼液(0.1%濃度)相比拉坦前列素滴眼液(0.005%濃度)對具有開角型青光眼或高眼壓症狀的受試者的安全性及功效。
具體而言,該等三期臨牀試驗旨在證明OT-301(NCX470)不遜於(主要療效指標)甚至優於拉坦前列素滴眼液(0.005%濃度),同時證明計劃給藥時長達12個月時耐受性良好。Nicox已於2020年6月在美國開始首項III期臨牀試驗。與Nicox合作開展OT-301國際多中心臨牀試驗將進一步提升公司的研究實力,及將更好地配合OT-301在中國的預期新藥申請。
OT-301(NCX470)由Nicox發明及開發。Nicox授予集團若干專利及專有技術的獨家權利,以於大中華地區、韓國及東南亞另外12個國家開發、生產、製作、進口、出口、使用、分銷、推廣、宣傳、許諾銷售及銷售OT-301(NCX470)。
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