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開拓藥業(09939.HK):普克魯胺治療新冠肺炎研究完成首例患者招募
格隆匯 08-21 21:43

格隆匯 8 月 21日丨開拓藥業(09939.HK)公佈,有關Applied Biology與公司訂立研究協議合作進行普克魯胺(GT0918)治療新型冠狀病毒肺炎的研究。於2020年8月20日,臨牀試驗(ClinicalTrials.gov識別碼:NCT04446429)已於巴西進行首例患者招募。

臨牀試驗屬前瞻性、干預性、安慰劑對照、雙盲、隨機並行分配研究,探討抗雄激素能否治療COVID-19。臨牀試驗包括接受度他雄胺加標準治療("度他雄胺組")及普克魯胺加標準治療("普克魯胺組")的兩個試驗組以及接受安慰劑加標準治療的一個活躍對照組。鑑於尚無批准用於治療COVID-19的藥物,因此將伊維菌素+阿奇黴素用作標準治療。為探討抗雄激素於COVID-19疾病中的可能保護作用,臨牀試驗預計招募381名年齡在50歲或以上且患有雄激素性脱髮的男性研究對象,當中度他雄胺組、普克魯胺組及對照組分別設置127名患者。臨牀試驗預期將於2021年1月底前完成。

普克魯胺(GT0918)為集團的主要在研藥物,正在中國進行轉移去勢抵抗性前列腺癌("mCRPC")的III期臨牀試驗,計劃於2020年提交新藥申請。普克魯胺(GT0918)亦正在美國進行mCRPC的II期臨牀試驗。普克魯胺(GT0918)是用於治療mCRPC的潛在同類最佳小分子AR拮抗劑,乃基於經精心研究的AR機制,並具有向下調節AR表達的創新化學結構。

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