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降胆固醇RNAi疗法再获佳绩，达到两项3期临床试验终点

2019-09-26 佚名 药明康德

高胆固醇血症RNAi疗法动脉粥样硬化性心血管病3期临床试验
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今日，The Medicines Company宣布，其降低胆固醇的RNAi疗法inclisiran，在治疗杂合子家族性高胆固醇血症（HeFH）的3期试验ORION-9，以及治疗动脉粥样硬化性心血管病（ASCVD）的3期试验ORION-10中，达到所有主要和次要终点。同时，还表现出良好的安全性和耐受性。这两项关键性试验的详细数据将在未来的美国心脏协会（AHA）科学论坛上公布。The Medicin

今日，The Medicines Company宣布，其降低胆固醇的RNAi疗法inclisiran，在治疗杂合子家族性高胆固醇血症（HeFH）的3期试验ORION-9，以及治疗动脉粥样硬化性心血管病（ASCVD）的3期试验ORION-10中，达到所有主要和次要终点。同时，还表现出良好的安全性和耐受性。这两项关键性试验的详细数据将在未来的美国心脏协会（AHA）科学论坛上公布。The Medicines Company预计将在今年年底向美国FDA递交inclisiran的新药申请（NDA），并在明年初向欧盟递交监管审查。

长期以来，高水平的低密度脂蛋白胆固醇（LDL-C）被认为与心血管疾病的高风险相关。高胆固醇血症患者LDL-C水平的严重升高经常会提高动脉粥样硬化风险，这可能导致包括心脏病或中风在内的心血管事件。很多ASCVD患者即便使用最大耐受剂量的脂质调节疗法，仍然有较高水平的LDL-C，进而导致较高的心血管事件发生风险。而HeFH则是严重的遗传性血脂异常，通常由LDL受体中的失活性突变引起，导致早发的心血管疾病。目前，HeFH和ASCVD均有相应的治疗方法，但很多患者在治疗后仍然无法让LDL-C水平达到标准，体内胆固醇的累积成为患者的终身负担。
 
Inclisiran是使用Alnylam Pharmaceuticals公司的GalNAc递送系统设计的靶向PCSK9的RNAi疗法，也是第一款可以降低LDL-C的RNAi疗法。它直接与编码PCSK9蛋白的mRNA结合，通过RNA干扰作用降低mRNA的水平，从而防止肝脏生成PCSK9蛋白。PCSK9蛋白的作用是抑制LDL受体的回收和再利用。因此，降低PCSK9蛋白的水平可以让更多LDL受体回到肝细胞表面，与更多LDL结合，将它们从血液中清除。与已有PCSK9抑制剂相比，这一疗法的一个重要优势是患者只需每年接受2-3次注射就可以达到控制胆固醇水平的效果，而已有PCSK9抑制剂需要每月接受一到两次注射。



▲Inclisiran作用机制


ORION-9和ORION-10是两项随机，双盲，含安慰剂对照组的3期临床试验，分别由482名LDL-C高水平的HeFH患者和1561名LDL-C高水平的ASCVD患者参与。这些患者即便使用最大耐受剂量的他汀类疗法，LDL-C水平仍然得不到控制。试验的主要终点是在接受治疗17个月之后，LDL-C水平与基线相比的下降幅度，以及在接受治疗18个月后，LDL-C水平与治疗3个月时相比的改变。试验结果表明，inclisiran达到了试验的所有主要和次要终点，并在治疗HeFH患者的试验中显示了持久的疗效。这些ORION研究是在广泛人群中使用RNAi疗法的第一组大型试验，它的结果可能预示RNAi疗法作为一种治疗疾病的新模式，能够在更广泛的领域得到应用。

“在ORION-9试验中，患者的LDL-C水平较基线时显著降低。我们对此结果感到非常的满意，”The Medicines Company首席开发官Peter Wijngaard博士说：“非常感谢参与这项研究的患者和机构，我们期待在未来的AHA会议上分享其详细结果。”

“在ORION-10试验中观察到的结果，再次证明了inclisiran的出色疗效，耐受性和安全性。”The Medicines Company首席执行官Mark Timney先生说：“同时，这进一步证实了inclisiran作为首款可以降低胆固醇的RNAi疗法，改善数百万ASCVD患者心血管疾病的治疗潜力。”

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    2020-11-20 lovetcm

    降胆固醇#RNAi疗法#，治疗#高脂血症#，针对PCSK9靶点，效果与单抗一致，但是半年只需要治疗一次！！

    0

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    2020-08-31 andy2087

    #3期临床#

    0

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    2020-09-07 yinxm8315

    #RNAi#

    0

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    2019-09-28 slcumt

    #3期临床试验#

    0

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    2019-09-26 衣带渐宽

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