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开拓药业-B(09939.HK)普克鲁胺治疗COVID-19临床试验取得积极结果
阿思达克 12-12 11:58
开拓药业-B(09939.HK)宣布,从正在巴西进行的普克鲁胺治疗COVID-19临床研究项目负责人(Andy Goren博士)处获悉,该临床试验初步结果显示普克鲁胺治疗COVID-19患者突出的效果及良好的安全性。

普克鲁胺是开拓药业自主研发的新一代雄激素受体(AR)拮抗剂,目前正在中国和美国进行前列腺癌和乳腺癌治疗的I-III期临床试验。COVID-19在全球的爆发後,开拓药业发现普克鲁胺在阻断AR信号同时,可以降低ACE-2及TMPRSS2蛋白的表达,後者是新冠病毒进入宿主细胞的两个关键蛋白。普克鲁胺治疗COVID-19的临床试验(NCT04446429)是一项随机、双盲和安慰剂对照的临床试验,旨在探索普克鲁胺在人体内延缓新冠病毒感染过程中的作用,从而减少COVID-19患者自轻症到重症的恶化。其共同主要终点包括30天内因COVID-19住院的受试者百分比和临床症状评估(采用7分等级量表,如使用呼吸机和死亡百分比)。该临床试验是由美国项目负责人和巴西研究者发起,开拓药业资助。根据114名普克鲁胺组受试者和100名安慰剂对照组受试者的初步结果分析显示,普克鲁胺组的住院率为0.8%,使用呼吸机百分比为0%,死亡百分比为0%;对照组住院率为27.0%,使用呼吸机百分比为9%,死亡百分比为2%。

开拓药业创始人、董事长兼首席执行官童友之博士表示,普克鲁胺作为AR拮抗剂,可以用於肿瘤和非肿瘤AR相关疾病的治疗,短期用药(1-2周)用於治疗COVID-19患者,安全性可控。公司非常高兴地看到普克鲁胺在治疗COVID-19的临床试验中获得积极结果,普克鲁胺有望通过降低TMPRSS2和ACE-2蛋白的表达,减少COVID-19患者自轻症到重症的恶化。目前公司正在中国和美国等国家积极准备国际多中心的III期临床试验,并希望获得普克鲁胺治疗COVID-19的紧急使用授权,尽早让更多COVID-19患者受益於普克鲁胺的治疗。

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