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美国FDA批准ABX464进行临床试验以治疗中重度溃疡性结肠炎

2020-01-21 Allan MedSci原创

ABX464中重度溃疡性结肠炎UC
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生物技术公司ABIVAX今天宣布，美国FDA已批准了研究性新药（IND）申请，允许在美国使用其主要候选药物ABX464进行临床试验以治疗中度至重度溃疡性结肠炎（UC）。预计首批美国患者将在2020年第二季度入组。

生物技术公司ABIVAX今天宣布，美国FDA已批准了研究性新药（IND）申请，允许在美国使用其主要候选药物ABX464进行临床试验以治疗中度至重度溃疡性结肠炎（UC）。预计首批美国患者将在2020年第二季度入组。

ABX464目前正在15个欧洲国家和加拿大被测试治疗中重度UC的有效性和安全性。这项正在进行中的IIb期临床试验（ABX464-103）现在将扩展至美国。12个月开放标签的最新数据显示，有75％的中度至重度活动性UC患者在免疫调节剂和/或皮质类固醇激素治疗失败后，经ABX464治疗得到临床缓解（基本上无症状）。在所有临床试验中，ABX464都是安全且耐受性良好的，没有严重的药物不良反应。不良事件的强度通常为轻度到中度，最常见不良反应为头痛、腹痛和腹泻。


原始出处：

https://www.firstwordpharma.com/node/1694810?tsid=4

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    2020-03-13 nymo

    #溃疡性#

    0

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    2020-06-28 juliusluan78

    #ABX464#

    0

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    2020-06-04 bugit

    #FDA批准#

    0

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    2020-01-23 10518098zz

    #美国FDA#

    0

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