RedHill的RHB-104完成了克罗恩病治疗的主要终点

2018-07-30 MedSci MedSci原创

RedHill制药今日表示,针对克罗恩病患者的实验性药物RHB-104的III期研究符合其主要终点,以及关键的次要终点。首席执行官Dror Ben-Asher表示:“我们期待与FDA讨论RHB-104的审批之路,并加快与潜在制药合作伙伴的讨论”。

RedHill制药今日表示,针对克罗恩病患者的实验性药物RHB-104III期研究符合其主要终点,以及关键的次要终点。首席执行官Dror Ben-Asher表示:我们期待与FDA讨论RHB-104的审批之路,并加快与潜在制药合作伙伴的讨论

该项III期试验将331名患有中度至重度活动性克罗恩病的患者随机接受RHB-104或安慰剂治疗。结果显示,对于主要终点,37%接受RHB-104的患者在第26周达到缓解,定义为克罗恩病活动指数(CDAI)值小于150,而安慰剂组仅为23%。此外,实验药物与安慰剂相比,在实现早期缓解方面具有显著的益处(定义为第16周的缓解),以及在第16周至第52周的持久缓解(定义为整个治疗期间的持续缓解)。RedHill补充说,在治疗52周时,RHB-104组的缓解率继续高于安慰剂,分别为27%和20%。该公司医疗总监Ira Kalfus表示:这项研究的有力结果表明,RHB-104可能成为克罗恩病的主要治疗选择


原始出处:

http://www.firstwordpharma.com/node/1581701?tsid=4#axzz5MVjkDWbV

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    2019-02-07 andy2100
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    2018-08-05 cscdliu

    学习了,谢谢

    0

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    2018-08-01 kafei

    学习了谢谢

    0

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    2018-07-31 西西er

    期待新药早点上市

    0

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    2018-07-31 太阳系小猪

    很赞!学习了!

    0

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    2018-07-31 飛歌

    厉害了我的妹

    0

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    2018-07-30 happsf

    学习

    0

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    2018-07-30 王秀

    学习了,涨知识了!

    0

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