由于安全性问题,Biogen停止其TGF-β单抗BG00011治疗特发性肺纤维化的中期研究

2019-09-18 不详 MedSci原创

根据ClinicalTrials.gov的最新消息,由于"安全问题",Biogen停止了其实验药物BG00011在特发性肺纤维化(IPF)患者中的II期研究。该试验于去年9月开始,预计将招募多达290名IPF的受试者。

根据ClinicalTrials.gov的最新消息,由于"安全问题",Biogen停止了其实验药物BG00011在特发性肺纤维化(IPF)患者中的II期研究。该试验于去年9月开始,预计将招募多达290名IPF的受试者。

该研究迄今已招募了109名患者,参与者随机接受每周一次的皮下注射BG00011或安慰剂,治疗52周。除评估BG00011与安慰剂疗效的主要终点外,该试验的次要目标还包括预测的用力肺活量(FVC)、无进展生存率、IPF恶化的发生率和FVC绝对下降率达10%以上的概率。

Biogen获得了BG00011,以前称为STX-100,作为2012年价值超过5.6亿美元收购Stromedix的一部分,该单克隆抗体旨在选择性地抑制TGF-β通路。

其他开发通过降低TGF-β活性来治疗IPF的药物公司包括Pliant Therapeutics,该公司今年早些时候公布了实验化合物PLN-74809的Ib期研究结果。当时,该公司首席医疗官ricLefebvre表示将"在2019年下半年启动williamhill asia 的IIa期计划......"

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    2020-03-11 sunylz
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    2019-11-14 changhe713
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    2019-09-20 qjddjq
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