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開拓藥業-B(09939.HK):福瑞他恩針對痤瘡適應症的I/II期臨牀試驗首批患者成功入組給藥
格隆匯 04-16 18:52

格隆匯 4 月 16日丨開拓藥業-B(09939.HK)發佈公吿,2021年4月16日,福瑞他恩凝膠針對痤瘡適應症的臨牀試驗已於中國完成首批患者招募併成功給藥。此次I/II期臨牀試驗為隨機、雙盲、安慰劑對照的臨牀研究,旨在評估福瑞他恩治療輕中度痤瘡患者的安全性、耐受性、藥代動力學和療效。

根據披露,痤瘡是一種慢性炎症性皮膚病,以開放或閉合的粉刺及炎性病變(如丘疹、膿皰或結節)為特點。痤瘡是一種常見疾病,特別是在青少年及年輕人中。痤瘡發病機制複雜,雄激素及其受體(AR)信號通路對皮脂腺及皮脂分泌的影響是引起痤瘡的重要因素之一。中國目前尚無有效的局部雄激素受體拮抗劑可用於痤瘡的治療,市場未被滿足的臨牀需求很大。

福瑞他恩是靶點明確的外用雄激素受體拮抗劑,其通過競爭性抑制皮膚組織內的雄激素與雄激素受體相結合,能夠局部控制雄激素過高所引起受體信號通路的激活而不改變人體內雄激素受體信號通路的活性。通過塗抹給藥的作用方式,福瑞他恩凝膠可抑制毛囊皮脂腺中的雄激素受體與雄激素的結合,從而實現痤瘡的治療。於2020年8月,美國食品藥品監督管理局批准了同靶點的痤瘡治療新藥,是痤瘡治療40年來獲批的創新藥物,已經驗證該作用機制可以很好地治療痤瘡。針對雄激素脱髮適應症,福瑞他恩目前正在中國進行II期臨牀試驗。

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