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兆科眼科-B(06622.HK):ZKY001有關角膜上皮缺損第II期臨牀試驗的最後一名患者入組
格隆匯 01-26 21:30

格隆匯1月26日丨兆科眼科-B(06622.HK)公吿,公司其中一項核心產品ZKY001有關角膜上皮缺損("CED")適應症的第II期臨牀試驗的最後一名患者已於2022年1月21日入組。該項試驗共有105名患者入組,為一項多中心、隨機、雙盲、安慰劑對照研究,以評估ZKY001用於治療CED的安全性及療效,同時旨在評估ZKY001的劑量以供日後開發。

ZKY001是一種包含七個氨基酸的肽,源自胸腺肽β4的功能片段,可與肌動蛋白結合,而肌動蛋白為一種在細胞結構及運動中起核心作用的蛋白質。除了公司領先的第III期創新資產用於治療乾眼症的環孢素A眼凝膠,ZKY001是另一個由公司自主開發、現時處於臨牀階段的項目。

ZKY001對於促進角膜傷口癒合的應用範圍廣泛,有望用於多種角膜癒合適應症。除正在進行的內皮角膜移植術后角膜上皮癒合第II期臨牀研究外,本公司目前正在發掘ZKY001另外三種適應症,包括經上皮雷射屈光角膜削切術("TPRK",一種治療近視的手術療法)、翼狀胬肉(角膜或結膜增生)及神經營養性角膜炎("NK",一種罕見角膜退化疾病)。

於2021年10月,公司公佈以ZKY001治療NK適應症的研究者發起試驗("IIT")已入組首名患者。IIT由廈門大學附屬廈門眼科中心的吳護平教授牽頭,計劃於2022年第二季度或前入組合共40名患者。公司亦預期於短時間內入組TPRK及翼狀胬肉適應症第II期臨牀試驗的首名患者。

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