開拓藥業-B(09939.HK)：普克魯胺在治療COVID-19的臨牀試驗中取得初期成果
格隆匯 12 月 11日丨開拓藥業-B(09939.HK)披露普克魯胺在治療COVID-19的臨牀試驗初期成果的最新消息。
普克魯胺是一種新的雄激素受體(AR)拮抗劑，目前正在中國及美國就治療前列腺癌和乳腺癌進行I至III期臨牀試驗。在COVID-19爆發後，公司發現普克魯胺可限制ACE-2及TMPRSS2(其在SARS-CoV-2整合至肺部宿主細胞方面發揮關鍵作用)的表達。
臨牀試驗屬隨機、雙盲及安慰劑對照臨牀試驗，旨在探討抗雄激素試劑在治療COVID-19中的作用。此為研究者發起之臨牀試驗(IIT)。臨牀試驗的初期分析包括319名招募患者。臨牀試驗的聯合主要終點為COVID-19患者住院率及COVID-19順序量表30日內的表現(世界衞生組織公佈的七點秩序測量等級(7-point ordinal scale)，其中包括機械通氣使用及死亡)。臨牀試驗的中期分析顯示，普克魯胺組的住院率為0.8%，而對照組則為27.0%。普克魯胺組的機械通氣使用百分比為0%，而對照組則為9.0%。普克魯胺組的死亡百分比為0%，而對照組則為2.0%。
下表載列普克魯胺組與對照組按截至2020年12月8日實時逆轉錄聚合酶鏈反應(rtPCR)測試(亦稱為RT-PCR測試)在首日至第30日期間陽性數字百分比的比較。rtPCR測試為對SARS-CoV-2的核酸進行定量檢測的實時逆轉錄聚合酶鏈反應測試，其中陽性結果顯示SARS-CoV-2核糖核酸存在。自第7日起，普克魯胺組的病毒載量大幅下降。
該項臨牀試驗由研究者發起(IIT)，而臨牀試驗的中期分析僅屬初期成果。成功研發普克魯胺在治療COVID-19取決於多項因素，且無法保證公司可在持續進行的未來臨牀試驗中獲得積極結果。
公司預期臨牀試驗的最終臨牀研究報告(CSR)將於2021年1月完成。集團現正積極籌備在中國及美國進行跨區域臨牀試驗(MRCT)。
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