開拓藥業-B(09939.HK)普克魯胺治療COVID-19臨床試驗取得積極結果
開拓藥業-B(09939.HK)宣佈,從正在巴西進行的普克魯胺治療COVID-19臨床研究項目負責人(Andy Goren博士)處獲悉,該臨床試驗初步結果顯示普克魯胺治療COVID-19患者突出的效果及良好的安全性。
普克魯胺是開拓藥業自主研發的新一代雄激素受體(AR)拮抗劑,目前正在中國和美國進行前列腺癌和乳腺癌治療的I-III期臨床試驗。COVID-19在全球的爆發後,開拓藥業發現普克魯胺在阻斷AR信號同時,可以降低ACE-2及TMPRSS2蛋白的表達,後者是新冠病毒進入宿主細胞的兩個關鍵蛋白。普克魯胺治療COVID-19的臨床試驗(NCT04446429)是一項隨機、雙盲和安慰劑對照的臨床試驗,旨在探索普克魯胺在人體內延緩新冠病毒感染過程中的作用,從而減少COVID-19患者自輕症到重症的惡化。其共同主要終點包括30天內因COVID-19住院的受試者百分比和臨床症狀評估(採用7分等級量表,如使用呼吸機和死亡百分比)。該臨床試驗是由美國項目負責人和巴西研究者發起,開拓藥業資助。根據114名普克魯胺組受試者和100名安慰劑對照組受試者的初步結果分析顯示,普克魯胺組的住院率為0.8%,使用呼吸機百分比為0%,死亡百分比為0%;對照組住院率為27.0%,使用呼吸機百分比為9%,死亡百分比為2%。
開拓藥業創始人、董事長兼首席執行官童友之博士表示,普克魯胺作為AR拮抗劑,可以用於腫瘤和非腫瘤AR相關疾病的治療,短期用藥(1-2周)用於治療COVID-19患者,安全性可控。公司非常高興地看到普克魯胺在治療COVID-19的臨床試驗中獲得積極結果,普克魯胺有望通過降低TMPRSS2和ACE-2蛋白的表達,減少COVID-19患者自輕症到重症的惡化。目前公司正在中國和美國等國家積極準備國際多中心的III期臨床試驗,並希望獲得普克魯胺治療COVID-19的緊急使用授權,儘早讓更多COVID-19患者受益於普克魯胺的治療。
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