赛诺菲(SNY.US)TSLP/IL-13双抗启动COPD II/III期临床

智通财经
Sep 26

智通财经APP获悉,9月24日,全球临床试验收录网站显示,赛诺菲(SNY.US)的TSLP/IL-13双抗Lunsekimig(SAR443765)推进至II/III期阶段,针对慢性阻塞性肺病(COPD)启动了两项II/III期临床试验(THESEUS和PERSEPHONE)。

两项研究拟纳入1884例患者,旨在评估Lunsekimig(两个剂量,皮下注射)对比安慰剂治疗控制不佳的嗜酸性粒细胞表型COPD成人患者的有效性和安全性。研究的主要终点为基线至第48周中重度COPD恶化的年化发生率。

此前,赛诺菲曾公布Lunsekimig治疗哮喘的Ib期概念验证研究数据。数据显示,哮喘患者经400mg Lunsekimig治疗28天后,呼出一氧化碳分数(FENO)较基线显著降低,较安慰剂组降幅为40.9ppb(p<0.0001)。此外,患者的2型炎症反应生物标志物水平亦显著降低。

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