開拓藥業-B(09939.HK):GT20029中國I期臨牀試驗結果
格隆匯11月24日丨開拓藥業-B(09939.HK)發佈公吿,其自主研發的新型靶向雄激素受體(“AR”)的蛋白降解嵌合體(“PROTAC”)化合物GT20029治療雄激素性脱髮和痤瘡的中國I期臨牀試驗主要結果,顯示其在健康受試者中具有良好的安全性、耐受性和藥代動力學特徵。GT20029基於公司自有PROTAC平台開發,為全球首個完成I期臨牀試驗的外用PROTAC化合物。
GT20029通過降解AR蛋白,從而有效阻斷AR信號通路激活導致的毛囊萎縮微型化作用,抑制毛髮變細、變軟和脱落,並且能夠有效抑制皮脂腺發育和皮脂分泌。GT20029僅在局部產生療效,通過限制皮膚滲透從而減少全身藥物暴露,以獲得更好的安全性。對二氫睾酮(“DHT”)誘導的小鼠模型藥效學研究的重複結果表明,GT20029可顯著減少脱髮,且有統計學差異。對丙酸睾酮(“TP”)誘導的金黃地鼠皮脂腺斑痤瘡模型藥效學研究的結果表明,GT20029可顯著抑制皮脂腺斑的增大,且有統計學差異。
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