绿谷药业宣布将在全球200个临床中心,开展阿尔茨海默症新药GV-971的全球临床试验

2020-01-06 不详 MedSci原创

去年11月,中国批准了上海绿谷药业的阿尔茨海默氏症新药GV-971(甘露特纳胶囊)。 现在绿谷药业宣布GV-971将在北美,欧盟,东欧,亚太地区和其他地区的200个临床中心进行测试。

去年11月,中国批准了上海绿谷药业的阿尔茨海默氏症新药GV-971(甘露特纳胶囊)。 现在绿谷药业宣布GV-971将在北美,欧盟,东欧,亚太地区和其他地区的200个临床中心进行测试。

它计划在2024年完成这些全球临床试验,然后将在2025年将该药物提交给美国FDA和欧洲药品管理局。

自美金刚以来,GV-971成为第一个被批准用于阿尔茨海默氏症的新药,美金刚于2002年在欧洲和2003年在美国获批。

绿谷药业临床研究的结果表明,轻度至中度阿尔茨海默氏症患者在36周内每天口服两次GV-971,在用于测试的ADAS-Cog 12量表上与安慰剂相比有统计学意义的改善认知功能。

该药物衍生自海藻,据绿谷药业表示是通过抑制β淀粉样蛋白原纤维形成并减少tau蛋白的过度磷酸化而起作用。同时可以减少周围和中枢神经系统的炎症,并恢复肠道中微生物的自然平衡。

如果绿谷药业如果能够进一步测试证明GV-971的功效,那么GV-971可能代表着一种全球认可的阿尔茨海默症新型治疗方法。

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