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辉瑞的Duchenne肌营养不良症基因疗法1b期展现出药效,但是安全问题引发了竞争对手股价上涨

2019-07-02 不详 MedSci原创

辉瑞的Duchenne肌营养不良症(DMD)基因疗法在1b期临床实验中已显示出疗效,但是安全问题也引发了关注,同时也导致其竞争对手股价的上涨。

辉瑞的Duchenne肌营养不良症(DMD)基因疗法在1b期临床实验中已显示出疗效,但是安全问题也引发了关注,同时导致了竞争对手股价的上涨。

来自1b期临床研究PF-06939926的数据显示,该基因疗法将"迷你肌营养不良蛋白"(DMD患者体内缺乏的蛋白质)的表达提高到10%至60%的正常水平。

其中两名患者进行了至少一年的随访,并显示出NorthStar门诊评估(NSAA)量表的适度增加,用于评估由肌肉萎缩疾病引起的症状。通常患有DMD的儿童患者将具有稳定的NSAA评分或在该时间范围内略微下降。

但同时该基因疗法也引起了安全问题。12名5至12岁儿童患者体内有6名在接受基因治疗后产生严重的免疫反应,包括急性肾损伤、溶血和血小板减少,并需要在重症监护、透析和使用Alexion的肾药Soliris(eculizumab)进行住院治疗。并且六名患者中有四名患者还出现其他副作用,包括恶心、呕吐和发烧。

辉瑞与Sarepta和Solid Biosciences竞争开发DMD的基因疗法,Sarepta已经推出一种治疗DMD的药物,去年AAVrh74.MHCK7候选药物的结果令人鼓舞。在周末前该公司股票收涨17%,Solid Bio同时也上涨了近14%。

辉瑞表示将在其3期临床中测试较高剂量与中间剂量的药效,并联合降低副作用风险的策略。

原始出处:


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    2020-04-15 lsndxfj
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    2020-05-14 makuansheng
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