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药物开发失败的概率:生物标记物指导的试验设计

2016-08-15 佚名 HPC药闻药事

本期Nature Reviews Drug Discovery发表了来自Genentech, Inc.公司Michael J. Townsend 和Joseph R. Arron的评论文章。文章讲到药物的候选分子可能因为各种各样的原因导致临床开发的失败,但是生物标记物指导的临床试验能够降低失败的风险。不论临床试验是否成功,生物标记物的指导能够让我们可以更好的理解和解释临床试验的结果。作者也引用了最

本期Nature Reviews Drug Discovery发表了来自Genentech, Inc.公司Michael J. Townsend 和Joseph R. Arron的评论文章。文章讲到药物的候选分子可能因为各种各样的原因导致临床开发的失败,但是生物标记物指导的临床试验能够降低失败的风险。不论临床试验是否成功,生物标记物的指导能够让我们可以更好的理解和解释临床试验的结果。作者也引用了最近关注比较多的一篇总结新药研发成功率的文章,显示生物标记物指导药物开发成功率是没有生物标记物的三倍。

作者首先描述了药物失败的四个原因,即错误的靶点,错误的分子,错误的结论,错误的病人(wrong target, wrong molecule, wrongoutcomes and wrong patients)。对于错误的靶点很容易理解,有些靶点与疾病的关系并不明确,盲目的开发很容易导致失败。

大家熟知的AD药物开发,市场非常大,但是这些年有大量的研发项目均以失败告终。对于靶点到底是Abeta还是Tau蛋白还是其他机制,这在学术上还存在争论。错误的分子主要是指成药性的问题,一个分子要成为药物,实际上是药理作用和成药性的平衡,也是物理化学性质和生物化学性质的平衡。

药物要达到实际的效果,需要穿过一层层的生物屏障(胃肠道吸收,血液蛋白结合以及肾脏的首过代谢等)达到靶标部位;当然脱靶效应导致的毒性也是非常关键的。错误的结论是指临床指标的不合理设定导致失败的风险,例如哮喘临床试验常常以呼吸量测定法作为临床指标,系统性红斑狼疮以主观和客观的综合结果作为临床指标。当然这些指标肯定与病人疾病相关,但是不同病人的表现可能不一样;分子机制与临床表现之间的发病机制也是不清晰的。

另外,事件驱动的临床指标很难开展对照试验,你是不可能让一个哮喘发作的病人做安慰剂的对照试验的。错误的病人是指临床表现相同的病人发病的分子机制可能不一样,比如肺癌可能是EGRF突变,也可能是KRAS或者ALK突变;因此找到对应发病分子机制的病人对于临床成功至关重要。

接下来作者描述了生物标记物的分类,可以分为预测下的生物标记物、药效动力学生物标记物、预后的生物标记物以及代理性生物标记物(predictive,pharmacodynamic, prognostic and surrogate biomarkers)。

预测性标记物可以用于提前鉴定对治疗有效的病人,进而找到准确的临床试验的人群。药效动力学生物标记物结合药代动力学可以确证靶标与疾病的关系,同时可以指导剂量的选择。

预后的生物标记物与疾病关联性很强,但是可能距离靶标通路有一定的距离。预后的标记物可以监测预后,也可以反过来选择参与临床试验的病人。

代理性生物标记物可以作为暂时性的或者早期概念验证(proof of concept),也可以反应给药之后的药效动力学变化。

最后总结了这些标志物的临床应用。药效动力学的Biomarker可以准确告诉我们候选分子是否有效的结合了靶标,预测性的Biomarker可以精准选择病人;这样药物开发的成功率会有明显提高。

特别是对一些复杂的疾病,可能多种信号通路都与疾病发生相关,但是不能确定哪些或者哪个是主要的,通过评估药物作用后药效Biomarker的情况可以帮组我们分清主次,甚至发现一些新的关键性的靶标通路。对于与毒性或者副作用相关的Biomarker,他们的合理应用也有助于筛选能够通过临床试验的药物分子。

最后作者提示Biomarker可以减低但是不能消除药物开发的失败。在Biomarker的指导下,不论试验成功或者失败,我们将获得更多有用的信息(比如为什么失败,失败在哪里,怎么改进等)。总的来说,合理的使用Biomarker对于药物开发非常关键。

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    2017-03-05 wjywjy
  2. 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    2016-08-18 1dd8a7c5m95(暂无匿称)

    学习了,赞一个!

    0

  3. 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createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfNLvzZhgPxRuUXgacXpPeW0x8Z3Qr9c3I2kTic4ZIpR29iaftYgkjRcbv982icYMtqANBPYBgPnOia6mVtX76qMXuc/0, createdBy=ebe61630855, createdName=1dd8a7c5m95(暂无匿称), createdTime=Thu Aug 18 17:48:00 CST 2016, time=2016-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=100451, encodeId=9a7e1004511c, content=学习了,赞一个!, beContent=null, objectType=article, channel=null, level=null, likeNumber=102, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfNLvzZhgPxRuUXgacXpPeW0x8Z3Qr9c3I2kTic4ZIpR29iaftYgkjRcbv982icYMtqANBPYBgPnOia6mVtX76qMXuc/0, createdBy=ebe61630855, createdName=1dd8a7c5m95(暂无匿称), createdTime=Thu Aug 18 17:48:00 CST 2016, time=2016-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1345336, encodeId=ab7c134533671, content=<a href='/topic/show?id=8907693e0fa' target=_blank 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    2016-08-18 1dd8a7c5m95(暂无匿称)

    学习了,赞一个!

    0

  4. 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    2016-08-18 1dd8a7c5m95(暂无匿称)

    学习了,赞一个!

    0

  5. 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    2016-08-18 1dd8a7c5m95(暂无匿称)

    学习了,赞一个!

    0

  6. 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  7. 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  8. 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  9. 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    2016-08-16 doctorJiangchao

    继续学习

    0

  10. 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    2016-08-16 doctorJiangchao

    继续学习

    0

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