87亿美元打水漂？艾伯维Emraclidine精神分裂症2期试验失败

药渡11-13

11月11日，艾伯维宣布，以90亿美元收购 Cerevel的核心药物EMPOWER在两项针对精神分裂症患者的 II 期EMPOWER-1和EMPOWER-2临床试验中失败。Emraclidine 作为每日一次口服单一疗法治疗精神病症状急性加重的精神分裂症成人患者的疗效，未达到其主要终点，即阳性和阴性第 6 周时与安慰剂组相比的症状量表（PANSS）总分。EMPOWER-1研究中，患者按1:1...

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AbbVie's Emraclidine Phase 2 trial fails in schizophrenia","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PAM":1,"ABBV":0.9,"EMPW.U":0.78},"content_text":"11月11日，艾伯维宣布，以90亿美元收购 Cerevel的核心药物EMPOWER在两项针对精神分裂症患者的 II 期EMPOWER-1和EMPOWER-2临床试验中失败。Emraclidine 作为每日一次口服单一疗法治疗精神病症状急性加重的精神分裂症成人患者的疗效，未达到其主要终点，即阳性和阴性第 6 周时与安慰剂组相比的症状量表 （PANSS） 总分。EMPOWER-1研究中，患者按1:1随机分为两个剂量水平（10mg/30mg）和安慰剂。EMPOWER-2研究以相同的方式对患者进行随机分配，但观察了15mg和30mg。入组患者均按每天服用一次emraclidine，测量6周的PANSS影响。EMPOWER-1的安慰剂组显示PANSS下降了13.5分，而10mg和30mg给药组分别下降了14.7分和16.5分；EMPOWER-2 显示安慰剂患者下降了 16.1 个百分点，而 15 mg和30mg给药组分别下降了18.5个百分点和14.2个百分点Emraclidine 耐受性良好，安全性与 1b 期试验中观察到的安全性相当。“虽然我们对结果感到失望，但我们将继续分析数据以确定下一步行动。”艾伯维研发执行副总裁兼首席科学官 Roopal Thakkar 医学博士说。消息传来，AbbVie的股价下跌超过12%。同时，Bristol Myers Squibb的股价因Emraclidine的失败而上涨约12%，这是自2006年3月以来的最高单日涨幅。Emraclidine是艾伯维斥资87亿美元收购神经科学生物技术公司Cerevel Therapeutics所得，加码神经领域布局。Emraclidine与BMS/Karuna新获批Cobenfy（KarXT）展开竞争。Emraclidine是一种毒蕈碱M4受体的正变构调节剂（PAM），被认为是一种潜在的下一代抗精神病药物。它通过选择性地调节M4受体来减少多巴胺信号，而不需要阻断D2受体，这可能减少现有抗精神病药物的副作用。近日，FDA 批准BMS的首创药物 KarXT（现称为 Cobenfy）用于口服治疗成人精神分裂症。BMS 通过三项注册试验的数据证明了 Cobenfy的疗效，这些试验表明该药物在阳性和阴性综合症量表上治疗精神分裂症方面有益。Cobenfy是M1/M4型毒蕈碱受体激动剂，而emraclidine是M4型毒蕈碱受体激动剂。所以仅针对M4的精神分裂症药物公司可能会出现问题，包括Neumora的精神分裂症药物NMRA-266和Neurocrine Biosciences的luvadaxistat。2024年4月，Neumora精神分裂症治疗药物NMRA-266因临床前数据显示该药物引发了兔子的抽搐被FDA叫停试验。NMRA-266 是 M4 毒蕈碱受体的高选择性正变构调节剂；2024年09月，Neurocrine的精神分裂症药物luvadaxistat二次临床二期失败，最终决定停止开发luvadaxistat（NBI-1065844）。综上所述，Emraclidine的失败也可以说明，这种药物以及更广泛的新神经科学项目背后的机制，并没有投资者想象的那么容易成功。在Cobenfy已经获批上市的情况下，Emraclidine的临床试验失败对AbbVie来说是一个重大打击，同时也可能改变精神分裂症治疗市场的竞争格局，对于BMS来说，相当于市场预期消除了Cobenfy最大的竞争对手，并可能将峰值销售预期推到一致预期40亿美元。药渡媒体商务合作媒体公关 | 新闻&会议发稿张经理：18600036371（微信同号）点击下方“药渡“，关注更多精彩内容","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-2","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"deviceId":"web-server-community-laohu8-v3","version":"4.29.1","shortVersion":"4.29.1","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2483060896"}