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科笛-B(02487.HK):CU-20401(重組突變膠原酶)治療頦下脂肪堆積II期臨牀試驗達到主要終點
格隆匯 11-29 06:32

格隆匯11月29日丨科笛-B(02487.HK)發佈公吿,集團的潛在1類新藥CU-20401(重組突變膠原酶)於中國開展的用於治療頦下脂肪堆積的II期臨牀試驗已獲得頂線數據。數據顯示,該臨牀試驗達到主要研究終點,結果具有統計學顯着性及臨牀意義。

該臨牀試驗是一項多中心、隨機、雙盲及安慰劑對照試驗,旨在評估CU-20401治療中度至重度頦下脂肪堆積患者的有效性和安全性,共入組108例受試者。

分析結果顯示:於有效性方面,主要療效終點數據顯示,低劑量CU-20401組和高劑量CU20401組的治療有效率均高於安慰劑對照組,且有效率差異均具有統計學意義。次要療效終點數據也展現出類似的療效優勢。於安全性方面,在整個臨牀試驗期間,CU-20401組(包括低劑量組和高劑量組)均未發生不良事件通用術語標準(CTCAE)定義的嚴重程度分級≥3級、導致研究藥物調整、導致退出臨牀試驗、嚴重不良事件(SAE)等不良事件。整體上,CU-20401展現出顯著且穩健的療效優勢,安全性良好。

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