Blood:C5补体抑制剂Crovalimab治疗阵发性夜间血红蛋白尿

2020-02-01 QQY MedSci原创

抑制补体C5是有明显临床症状的阵发性夜间血红蛋白尿(PNH)患者的标准护理(SoC)。持续完全抑制末端补体途径和高血清浓度的C5对药物开发构成挑战,导致只能采用静脉注射(IV)治疗。Crovalimab,一种序贯单克隆抗体回收技术(SMART)抗体,用于C5抑制疾病的皮下给药。近期,研究人员开展了一项三部分的开放性适应性I/II期试验,以评估Crovalimab在健康志愿者(部分一)、未进行过补体

抑制补体C5是有明显临床症状的阵发性夜间血红蛋白尿(PNH)患者的标准护理(SoC)。持续完全抑制末端补体途径和高血清浓度的C5对药物开发构成挑战,导致只能采用静脉注射(IV)治疗。

Crovalimab,一种序贯单克隆抗体回收技术(SMART)抗体,用于C5抑制疾病的皮下给药。

近期,研究人员开展了一项三部分的开放性适应性I/II期试验,以评估Crovalimab在健康志愿者(部分一)、未进行过补体阻滞的PNH患者(部分二)和C5抑制剂治疗的PNH患者(部分三)中的安全性、药代动力学、药效学和疗效。29位患者被纳入部分二(10位)和部分三(19位)研究。

Crovalimab浓度超过了预定的100μg/mL,导致部分二和部分三研究的患者的末端补体途径被持续完全抑制。溶血活性和游离C5水平被抑制在临床相关阈值以下。安全性与已知的C5抑制谱一致。

一如预期,所有19例改用Crovalimab的患者均观察到药物靶点-药物复合物(DTDC)的形成,2/19位患者出现短暂的轻中度血管性皮肤反应。这两个事件均在持续应用Crovalimab治疗后得到解决。

每4周皮下注射一次crovalimab(680mg),可为PNH患者提供持续完全的末端补体途径抑制,为进一步的临床发展提供了保障。

原始出处:

Alexander Roth, et al.The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria.Blood. January 24, 2020. 

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    2020-09-26 jklm09
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    2020-11-15 ms6000000249002173

    请问C5补体有买吗?

    0

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    2020-02-19 snf701207
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欧盟批准C5补体抑制剂ULTOMIRIS用于治疗阵发性睡眠性血红蛋白尿(PNH)成人患者

亚力兄制药公司宣布,欧盟委员会已批准ULTOMIRIS(ravulizumab)--第一个也是唯一的长效C5补体抑制剂,每八周服用一次用于治疗高疾病活动度的阵发性睡眠性血红蛋白尿(PNH)成年患者。

FDA将优先审查C5补体单抗Eculizumab用于治疗视神经脊髓炎NMOSD患者

Alexion Pharmaceuticals公司今天宣布,FDA接受优先审查sBLA( eculizumab),该公司的第一个C5补体抑制剂,用于治疗具有抗水通道蛋白-4(AQP4)自身抗体的神经脊髓炎视神经疾病(NMOSD)患者。