李氏大藥廠(00950.HK):兆科眼科於中國成功招募最後一名病人在第三期臨牀試驗中使用環孢素A眼凝膠
格隆匯 4 月 12日丨李氏大藥廠(00950.HK)宣佈,於2021年4月9日,集團聯營公司兆科眼科有限公司("兆科眼科")於中國成功招募最後一名病人在第三期臨牀試驗中使用環孢素A眼凝膠(一種治療乾燥性角膜結膜炎(乾眼症)的藥物)。此試驗涉及41間臨牀試驗中心,招募總共644名病人。兆科眼科計劃於2021年第四季向國家藥品監督管理局("國家藥監局")提交新藥申請。
第三期的目的為比對環孢素A眼凝膠與安慰劑對中至嚴重程度乾眼症對象的多中心、隨機、雙盲、安慰劑對照、效能及安全性研究(COSMOS;clinicaltrials.gov登記編號:NCT04541888),旨在評估環孢素A眼凝膠治療乾燥性角膜結膜炎(乾眼症)的效能及安全性。對上第二期研究結果顯示0.05%環孢素A眼凝膠(每天一次)的效能及安全特性與Restasis(0.05%環孢素A,每天兩次)類近。
在第二期研究成功完成後,第三期臨牀試驗乃經諮詢中國藥品審評中心後設計。中至嚴重程度乾眼症病人隨機接受(i)每晚一次環孢素A眼凝膠;或(ii)每晚一次安慰劑,為期84天。主要終點指標為治療結束時(84±3天)的下角膜螢光素染色法分數(ICSS)。次要終點指標包括乾眼症的徵象及症狀。試驗期間亦會監察安全參數。
環孢素A眼凝膠乃一種創新的水凝膠配方,有別於Restasis的油性乳劑配方。相比Restasis,水凝膠配方的臨牀前研究顯示大大改善環孢素A在淚水及眼表組織的曝露量。相比Restasis每天兩次的用法,環孢素A眼凝膠每晚一次的用法能避免病人於日間眼部因用藥而引起的潛在短暫不適,預期會顯著改善病人的生活質素及療程依從性。
據悉,環孢素A為天然的環狀多肽免疫抑制劑,擔當鈣調神經磷酸酶抑制劑,抑制T淋巴細胞釋放促炎性細胞因子。兆科眼科開發的環孢素A眼凝膠為專利產品,在臨牀前研究中顯示出較乳劑配方(Restasis)具有更佳的藥代動力學特性。於第二期直接比較對照試驗中,環孢素A眼凝膠每天一次的用量展示出的療效及安全特性至少與Restasis(每天兩次)類近。環孢素A眼凝膠目前正於中國進行第三期開發,以治療中至嚴重程度乾燥性角膜結膜炎(乾眼症)。
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