開拓藥業-B(09939.HK):AR-PROTAC(GT20029)治療脱髮中國II期臨牀試驗完成首例受試者入組
格隆匯4月14日丨開拓藥業-B(09939.HK)公佈,於2023年4月14日,其自主研發的靶向雄激素受體(AR)的新型蛋白降解嵌合體(PROTAC)化合物GT20029治療男性雄激素性脱髮(AGA或脱髮)在中國開展的II期臨牀試驗完成首例受試者入組。
GT20029基於公司自有的PROTAC平台開發,是全球首個進入II期臨牀試驗階段的外用PROTAC化合物。該項II期臨牀試驗是一項多中心、隨機、雙盲、安慰劑對照的研究,用以評估GT20029治療中國成年男性脱髮的有效性和安全性,並確定III期臨牀試驗推薦給藥劑量。該項研究的主要臨牀終點為治療12周與安慰劑相比目標區域內非毳毛數量(TAHC)對比基線的變化,計劃在全國12家中心納入180名受試者。
於2022年11月及2023年2月,公司分別公佈GT20029治療雄激素性脱髮和痤瘡的中國(針對健康受試者)及美國(針對健康受試者、脱髮受試者和痤瘡受試者)I期臨牀試驗頂線數據,顯示其在健康受試者、脱髮受試者及痤瘡受試者中均具有良好的安全性、耐受性和藥代動力學特徵。
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