開拓藥業-B(09939.HK):福瑞他恩治療男性雄激素性脱髮關鍵性臨牀試驗獲中國NMPA同意開展
格隆匯11月24日丨開拓藥業-B(09939.HK)公吿,董事會欣然宣佈,其自主研發、潛在同類首創的福瑞他恩(KX-826)治療男性雄激素性脱髮("AGA")的關鍵性臨牀試驗(III期臨牀試驗)新藥研究(IND)申請獲中國國家藥品監督管理局("NMPA")同意。福瑞他恩是全球首個進入III期臨牀試驗用於AGA治療的外用雄激素受體(AR)拮抗劑。
該項III期臨牀試驗是一項隨機、雙盲、安慰劑對照、多中心的研究,樣本量為416人,試驗時間為24周。該項III期試驗旨在評估福瑞他恩治療中國成年男性AGA患者的有效性和安全性,主要終點為目標區域內非毳毛(TAHC)數量變化(治療24周與基線的變化)。試驗計劃在中國20多家醫院開展,主要研究者(PIs)為北京大學人民醫院張建中教授和復旦大學附屬華山醫院楊勤萍主任,預計將在2022年1月初開始受試者入組。
此前,公司於2021年9月8日宣佈福瑞他恩用於治療男性AGA患者的中國II期臨牀試驗已達到主要研究終點,結果顯示了良好的有效性和安全性,並且確定了III期臨牀的用藥劑量。
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