vTv Therapeutics公司阿尔茨海默症候选药物临床试验失败

2018-04-12 MedSci MedSci原创

阿尔兹海默症是一种神经系统退行性疾病,自2003年批准美金刚以来,15年都没有新药面世。大量基础研究表明晚期糖基化终产物受体(RAGE)可能参与调控阿尔茨海默症中淀粉样蛋白的累积、脑部炎症以及慢性神经元功能的丧失,vTv Therapeutics公司针对该靶点投入近18年的心血开发了小分子拮抗剂Azrainragon。

阿尔兹海默症是一种神经系统退行性疾病,自2003年批准美金刚以来,15年都没有新药面世。大量基础研究表明晚期糖基化终产物受体(RAGE)可能参与调控阿尔茨海默症中淀粉样蛋白的累积、脑部炎症以及慢性神经元功能的丧失,vTv Therapeutics公司针对该靶点投入近18年的心血开发了小分子拮抗剂Azrainragon。

针对Azrainragon的临床三期试验(STEADFAST)由两个独立且安慰剂相同的试验组成(包括Part A和Part B)。Part A 中Azrainragon治疗组,患者认知能力(ADAS-cog)比基线降低4.4%,痴呆水平(CDR-sb)比基线降低1.6%;而与安慰剂分别降低3.3%和1.6%相比,差异并不显著。另一方面,该药物具有良好的耐受性,18个月内有25%的戒断率。

vTv Therapeutics公司表示将停止目前涉及Azrainragon的临床研究,包括开放标签扩展研究和STEADFAST的Part B。考虑到Part B中已经取得的进展,按照研究计划,Part B中的患者将继续完成12个月的治疗。Part A和Part B中的所有数据将也被继续评估,从而判断出Azrainragon的潜在优势和未来使用情况。

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    2019-01-20 feather89
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  6. 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  7. 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    2018-04-13 QQ25ed180f

    研究的过程.也可能面临瓶颈-

    0

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