英国批准Aplidin(plitidepsin)治疗COVID-19的III期临床试验

2021-02-18 Allan MedSci原创

Aplidin(plitidepsin)通过阻断人类细胞中存在的eEF1A蛋白发挥作用,SARS-CoV-2使用它来复制和感染其他细胞。

制药公司PharmaMar今天宣布,它已获得英国药品和医疗产品监管局(MHRA)的批准,将开展NEPTUNO III期临床试验,该试验旨在评估Aplidin(plitidepsin)治疗中度COVID-19住院患者的有效性和安全性。

Aplidin(plitidepsin)通过阻断人类细胞中存在的eEF1A蛋白发挥作用,SARS-CoV-2使用它来复制和感染其他细胞。这种封锁可防止病毒在细胞内繁殖,使其无法存活,并防止其传播至其他细胞。

英国MHRA是第一个授权进行NEPTUNO III期试验的监管机构。该试验的设计方案基于在I-II期APLICOV-PC试验的结果,该研究证明了Aplidin(plitidepsin)治疗COVID-19的安全性和有效性。

NEPTUNO III期试验将在英国、其他欧洲以及世界其他国家的大约70个中心招募600多例患者。这项研究的主要目的是比较两种剂量水平(1.5或2.5毫克)的Aplidin(plitidepsin)与标准护理相比的优势。主要终点指标是患者在第8天(±1)时完全恢复的百分比。

 

原始出处:

https://www.firstwordpharma.com/node/1801577?tsid=4

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    2021-09-29 柳叶一刀
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    2021-05-15 juliusluan78
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    2021-02-20 风铃824
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