開拓藥業-B(09939.HK):福瑞他恩(KX-826)在中國完成雄激素性脱髮適應症II期臨試患者入組
格隆匯 12 月 30日丨開拓藥業-B(09939.HK)發佈公吿,2020年12月29日,集團自主研發的、潛在同類首創局部藥物福瑞他恩(KX-826)已在中國完成針對雄激素性脱髮適應症的II期臨牀試驗患者入組(“II期臨牀試驗”)。
II期臨牀試驗屬多中心、隨機、雙盲、安慰劑對照臨牀研究,以評估福瑞他恩對於治療中國成年男性雄激素性脱髮患者的安全性及功效。集團根據II期臨牀試驗方案,從全國九個地點招募共計120名男性雄激素性脱髮患者,並將彼等隨機分為四組,每組30名患者。四組用藥分別為每日兩次(BID)2.5毫克福瑞他恩、每日一次(QD)5毫克福瑞他恩、每日兩次(BID)5毫克福瑞他恩以及安慰劑。集團將就II期臨牀試驗進行安全性及功效評估,並評價福瑞他恩在患者中的羣體暴露情況。功效評估將從使用測試藥物開始每6周進行一次,直至第24周結束。
II期臨牀試驗尚未受到COVID-19疫情的重大影響。集團預計於2021年確定II期臨牀試驗臨牀研究報吿(CSR)及發佈數據並於2021年下半年展開III期臨牀試驗。福瑞他恩亦在美國開展針對雄激素性脱髮適應症的臨牀試驗,於2020年8月3日,已經完成Ib期臨牀,目前正在分析及評估數據,預計於2021年上半年確定臨牀研究報吿(CSR)及發佈數據。福瑞他恩針對痤瘡適應症已於2020年9月份自中國國家藥監局(NMPA)獲得臨牀試驗批件。
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