索马鲁肽治疗阿尔茨海默病!诺和诺德直接启动3700人IIIa期试验

2020-12-17 医药魔方 医药魔方

12月16日,诺和诺德宣布将开展口服司美格鲁肽(索马鲁肽)治疗阿尔茨海默病的III期研究项目。诺和诺德此次的决定是在评估了临床前动物模型数据、真实世界研究数据以及大型心血管结局研究的事后分析结果后做出

12月16日,诺和诺德宣布将开展口服司美格鲁肽(索马鲁肽)治疗阿尔茨海默病的III期研究项目。诺和诺德此次的决定是在评估了临床前动物模型数据、真实世界研究数据以及大型心血管结局研究的事后分析结果后做出的,同时也与监管机构进行了讨论。

动物模型研究数据提示GLP-1在阿尔茨海默症治疗中发挥了关键作用,包括改善记忆功能和减少磷酸化tau蛋白的积累,司美格鲁肽也被证明可减轻对认知和身体机能有潜在影响的神经炎症。根据在丹麦注册的美国Truven索赔数据库和美国FDA FAERS数据库的真实世界研究证据,GLP-1治疗与痴呆风险降低之间也存在潜在的联系。

此外,诺和诺德对LEADER,SUSTAIN 6和PIONEER 6这三项大型心血管结局研究的试验数据进行了事后分析,15820例2型糖尿病患者中位随访时间3.6年,发现47人患有痴呆(早期轻度阿尔茨海默症),其中32人使用安慰剂,15人使用了GLP-1药物(利拉鲁肽或司马格鲁肽)。从统计学上看,痴呆症的发生率显着降低了53%,从而为GLP-1治疗痴呆提供了证据。

按照计划,诺和诺德将直接启动一项涉及大约3700例早期阿尔茨海默病患者的关键IIIa期研究,于2021H1开始患者招募,主要评估口服司美格鲁肽(14mg,每日1次)相比安慰剂的疗效和安全性差异,给药时间预计持续大约2年。

诺和诺德执行副总裁兼首席科学官Mads Krogsgaard Thomsen说:“我们渴望解决严重慢性疾病中高度未满足的医疗需求,因此我们很高兴能够启动司美格鲁肽开发用于治疗阿尔茨海默症的3期项目。在过去的几十年中,阿尔茨海默症一直是被广泛关注的研究的领域,但不幸的是该领域始终没有重大的医学突破。由于日益增长的为满足医疗需求,以及GLP-1在阿尔茨海默症治疗中潜在作用的证据不断增加,我们将会探索口服司美格鲁肽对于早期阿尔茨海默症的治疗益处。”

阿尔茨海默症是日益突出的公共卫生问题之一,对患者及其家属造成了严重的不利影响,并导致全球社会经济负担不断加重。目前全球范围内估计有7000万 ~1亿人患有早期阿尔茨海默症(轻度认知障碍和轻度痴呆)。

口服司美格鲁肽(7mg和14mg)已经在美国、欧洲和日本获批,辅助饮食和运动用于改善2型糖尿病患者的血糖控制。其在设计9543例患者的10项临床试验中显示了出色的安全性和耐受性,最常见的不良事件主要是一过性的轻度恶心。

12月4日,诺和诺德刚向FDA提交了每周皮下注射1次司美鲁肽2.4mg的上市申请,辅助低脂饮食和加强运动用于伴有至少一种体重相关合并症的肥胖(BMI≥30kg/m2)或超重(BMI≥27kg/m2)成人患者的慢性体重管理。

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    2021-01-17 juliusluan78
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    2021-03-01 zy&kt

    很有启发

    0

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    2020-12-18 三生有幸9135

    动物模型研究数据提示GLP-1在阿尔茨海默症治疗中发挥了关键作用,包括改善记忆功能和减少磷酸化tau蛋白的积累,司美格鲁肽也被证明可减轻对认知和身体机能有潜在影响的神经炎症

    0

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