Duvakitug

▎药明康德内容团队编辑 赛诺菲（Sanofi）与梯瓦（Teva Pharmaceuticals）日前公布了其共同开发的在研单抗duvakitug在2b期临床试验RELIEVE UCCD中获得的详细结果。试验结果显示，接受duvakitug治疗的溃疡性结肠炎（UC）和克罗恩病（CD）患者在第14周时达成缓解。新闻稿表示，这一结果展现了duvakitug成为“best-in-class”疗法的潜力。两家公司预计在今年下半年启动3期临床试验。 UC与CD是炎症性肠病（IBD）的两种主要类型，属于胃肠道（GI）的慢性炎症性疾病，会导致腹痛、腹泻、直肠出血、疲劳和体重下降等症状。长期炎症可引发纤维化等并发症，纤维化是指肠壁瘢痕组织过度累积，可能导致肠道狭窄和阻塞，患者常需住院或手术治疗。目前，IBD尚无治愈方法，治疗目标是诱导和维持缓解，防止病情复发。 2b期临床试验数据显示，接受duvakitug治疗的UC患者中，36%的低剂量组和48%高剂量组患者实现临床缓解（clinical remission），此数值在安慰剂组仅为20%。经安慰剂校正后，低剂量组和高剂量组患者在第14周的临床缓解率分别为16%（p=0.050）和27%（p=0.003）。 此外，duvakitug组的临床应答（clinical response）率分别为81%（低剂量组）和70%（高剂量组），安慰剂组这一数值为52%。Duvakitug组的内镜改善率分别为45%（低剂量组）和50%（高剂量组），安慰剂组为23%。 在CD患者中，26%的低剂量组和48%的高剂量组患者达到内镜缓解的主要终点，此数值在安慰剂组为13%。经安慰剂校正后，低剂量组和高剂量组患者在第14周的内镜缓解率分别为13%（p=0.058）和35%（p<0.001）。 Duvakitug是一款潜在“best-in-class”的人源IgG1-λ2单抗，靶向TL1A。TL1A通过与其受体DR3结合，可放大炎症反应并加速IBD相关纤维化的进展。靶向TL1A有望缓解IBD患者的过度免疫反应。赛诺菲与梯瓦在2023年达成合作，共同开发并商业化duvakitug，用于治疗UC和CD。赛诺菲主导3期临床开发项目。梯瓦负责产品在欧洲、以色列及指定国家与地区的商业化推广，赛诺菲则负责北美、日本、其他亚洲地区及全球其他市场的商业化。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放 参考资料： [1] Teva and Sanofi Present New Positive Phase 2b Study Results at ECCO 2025 Reinforcing Best-in-Class Potential of Duvakitug (Anti-TL1A) in Ulcerative Colitis and Crohn’s Disease. Retrieved February 24, 2025, from https://www.globenewswire.com/news-release/2025/02/22/3030763/0/en/Teva-and-Sanofi-Present-New-Positive-Phase-2b-Study-Results-at-ECCO-2025-Reinforcing-Best-in-Class-Potential-of-Duvakitug-Anti-TL1A-in-Ulcerative-Colitis-and-Crohn-s-Disease.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新

New data are informing Sanofi and Teva’s phase 3 plans. \n Sanofi has shared a deeper dive into its 469 million euro ($491 million) bowel disease bet, publishing phase 2 data that provide a clearer look at how the Teva-partnered prospect compares to Merck & Co. and Roche’s rival candidates.The French drugmaker paid Teva for rights to co-develop and co-commercialize the anti-TL1A therapy in 2023. Late last year, the partners shared top-line data from a phase 2 trial in ulcerative colitis and Crohn’s disease. The December readout showed duvakitug improved outcomes in the two most common forms of inflammatory bowel disease but left key questions about the molecule’s prospects unanswered.Monday, Sanofi and Teva filled in some of the gaps at the 20th Congress of the European Crohn’s and Colitis Organisation. The updated readout shows duvakitug’s effect on key secondary endpoints and in subgroups of advanced therapy naïve and experienced patients.After 14 weeks, the rates of endoscopic improvement were 45% and 50%, respectively, on the low and high doses of duvakitug. Sanofi and Teva reported endoscopic improvement in 23% of placebo patients. The secondary endpoint sheds light on how duvakitug compares to the competition on a key outcome in ulcerative colitis. Sanofi and Teva’s 27% placebo-adjusted rate of endoscopic improvement falls in the middle of the rivals’ range. Roivant, the source of Roche’s TL1A prospect, reported a 21% delta compared to placebo after 12 weeks. Prometheus Biosciences, which Merck acquired, saw a 31% placebo-adjusted rate of endoscopic improvement at Week 12 of its phase 2 ulcerative colitis trial.The new duvakitug data also clear up the question of whether the hit on the primary endpoint of clinical remission was driven by subgroup performance. Sanofi and Teva saw higher rates of clinical remission on duvakitug than placebo regardless of whether patients had previously tried an advanced therapy. The partners reported the highest placebo-adjusted rates in advanced therapy experienced participants.Similarly, endoscopic response rates in the Crohn’s cohort were higher on duvakitug than placebo in naïve and experienced patients. The pattern is less clear in the Crohn’s data. The partners reported the highest and lowest placebo-adjusted rates in advanced therapy experienced participants, with the low dose and high dose figures coming in at 7% and 44%, respectively.The data are informing Sanofi and Teva’s phase 3 plans. Last month, Teva Chief Medical Officer Eric Hughes, M.D., Ph.D., told investors the partners had just “put the final touches” to the phase 3 design. The design is “really based on the modeling and simulation that we\'ll use from this first study,” the Teva executive said. In a note discussing the results this morning, analysts at Leerink Parners said the latest data reinforce duvakitug\'s “exceptional profile.” The analysts expect Sanofi to bring in 1 billion euros ($1.05 billion) in sales of the drug in 2032.