优化配方，实现每日1次给药！辉瑞继续推进口服GLP-1开发

医药魔方07-12

7月11日，辉瑞表示，根据正在进行的药代动力学研究（NCT06153758）的结果，已经确定了口服GLP-1R激动剂Danuglipron（PF-06882961）每日1给药的优选缓释制剂配方。此外，辉瑞计划在2024年下半年启动该缓释制剂的剂量优化研究以评估多个剂量的疗效和安全性，为注册性研究提供参考。该研究是一项随机、开放标签临床试验，旨在评估Danuglipron口服速释制剂和口服缓释制剂在...

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Pfizer continues to advance oral GLP-1 development","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PFE":1,"GLP":1},"content_text":"7月11日，辉瑞表示，根据正在进行的药代动力学研究（NCT06153758）的结果，已经确定了口服GLP-1R激动剂Danuglipron（PF-06882961）每日1给药的优选缓释制剂配方。此外，辉瑞计划在2024年下半年启动该缓释制剂的剂量优化研究以评估多个剂量的疗效和安全性，为注册性研究提供参考。该研究是一项随机、开放标签临床试验，旨在评估Danuglipron口服速释制剂和口服缓释制剂在健康成年人中的药代动力学和安全性。研究结果表明，新的制剂配方可使Danuglipron实现每日1次给药。其安全性与既往研究一致，未观察到患者肝酶升高现象。在此之前，Danuglipron的用药频率为每日2次。去年12月，Danuglipron（每日2次）治疗不伴2型糖尿病的肥胖成人患者的IIb期研究达到主要终点。数据显示，治疗第26周时，Danuglipron所有剂量组患者的体重变化均较安慰剂组明显（-4.8%~-9.4% vs. +0.17%）；治疗第32周时，Danuglipron所有剂量组患者的体重变化仍然较安慰剂组明显（-6.9%~-11.7% vs. +1.4%）。经安慰剂调整后，Danuglipron组在第26周和第32周的平均体重下降幅度分别为-5%~-9.5%和-8%~-13%。Danuglipron（每日2次）虽有不错的减重效果，但在当下的竞争环境中已不具备优势。GLP-1疗法引领者诺和诺德的口服司美格鲁肽（Rybelsus）为每日1次口服片剂，该片剂已于2019年在美国获批上市，适应症为2型糖尿病。就在去年，中高剂量Rybelsus也顺利完成了减肥III期研究，其进度远领先于其它公司的GLP-1产品。而礼来的小分子GLP-1R激动剂Orforglipron同为每日1次口服片剂，也已进入III期阶段，其开发进度直追Rybelsus。此外，还有多家企业开发的口服GLP-1药物正在顺利推进中期开发。面对这样的竞争情况，辉瑞只能选择放弃Danuglipron的每日2次版本，对制剂配方进行优化以实现更低的给药频率。另一方面，Danuglipron（每日2次）的胃肠道反应发生率（恶心73%，呕吐47%，腹泻25%）较高，停药率也较高（50%），这也是辉瑞考虑开发每日1次口服版本的原因。目前看来，辉瑞的速度还不算太慢，未来仍有机会从减重市场分一杯羹。辉瑞研发部首席科学官兼总裁Mikael Dolsten博士表示：“肥胖是辉瑞的一个关键治疗领域，我们拥有强大的产品管线，包括3个临床候选药物和多个临床前候选药物。Danuglipron是其中进展最快的一款产品，其每日2次口服版本已显示出良好的疗效。在对之前的IIb期数据和试验设计进行全面分析后，我们相信，改进缓释制剂和优化试验设计可以将具有竞争力的口服GLP-1分子Danuglipron推进到注册性研究中，以解决肥胖患者当前和持续的医疗需求。”推荐阅读再折戟！辉瑞终止推进小分子GLP-1R激动剂III期开发口服小分子GLP-1R激动剂，下一个现金牛？全球药企的GLP-1梦Copyright © 2024 PHARMCUBE.All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。—医药决策者们，请进—","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","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":"4.26.2","shortVersion":"4.26.2","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/2450334365"}