| Regeneron and Sanofi Provide Update on Ongoing Dupixent® (dupilumab) Chronic Spontaneous Urticaria Phase 3 Program February 18, 2022 In this article: | Analyst Report: Regeneron Phars, Inc TARRYTOWN, N.Y. and PARIS, Feb. 18, 2022 /PRNewswire/ -- In a Phase 3 trial in patients refractory to omalizumab, Dupixent did not reach statistical significance in interim analysis despite numeric improvements observed across key endpoints; trial will be stopped due to futility Positive results from a previous Phase 3 trial in biologic-naïve patients showed Dupixent significantly reduced itch and hives compared to standard-of-care antihistamines alone Companies remain committed to advancing Dupixent for patients with chronic spontaneous urticaria uncontrolled on antihistamines and are evaluating next steps Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced a Phase 3 trial (CUPID STUDY B) evaluating Dupixent® (dupilumab) in patients with chronic spontaneous urticaria (CSU) will stop due to futility, based on a pre-specified interim analysis. The trial, which assessed Dupixent added to antihistamines in patients refractory to omalizumab at 24 weeks, showed positive numerical trends in reducing itch and hives (the primary endpoints) but did not meet statistical significance during an interim analysis conducted by an independent review committee. The safety data were generally consistent with the known safety profile of Dupixent in its approved indications. The LIBERTY-CUPID pivotal program was initiated in 2020 with an accelerated direct-to-Phase 3 strategy. The previously reported Phase 3 trial, which evaluated a different group of patients who were biologic-naïve (i.e., not previously treated with omalizumab), met its primary and all key secondary endpoints at 24 weeks, showing that adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives compared to antihistamines alone. The companies remain committed to advancing Dupixent for patients with CSU uncontrolled on antihistamines and are evaluating next steps. Chronic spontaneous urticaria is a very complex disease, and these data add to the body of evidence assessing the underlying drivers of disease burden, including the potential role of interleukin-4 and interleukin-13, said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. While Dupixent did not show a significant benefit in the most difficult-to-treat patients who remain refractory to all approved medicines, we are carefully assessing the potential role of Dupixent in CSU based on the success of the first Phase 3 trial in biologic-naïve patients, where Dupixent nearly doubled the reduction in itch and urticaria activity. Detailed results from the first trial will be presented at the AAAAI Annual Meeting later this month, and the companies expect to share results from the second trial in a scientific forum. Regeneron and Sanofi are rapidly advancing a broad clinical development program to evaluate Dupixent in diseases with significant unmet need and where type 2 inflammation may play a role. The companies also recently announced positive Phase 3 results in eosinophilic esophagitis (EoE) and prurigo nodularis (PN), and additional results are also expected later this year in pediatric EoE, chronic inducible urticaria-cold (CindU), and hand and foot atopic dermatitis. Regeneron和赛诺菲提供正在进行的Dupixent®（dupilumab）慢性自发性荨麻疹3期计划的最新情况 2022年2月18日 在这篇文章中。 | 分析师报告。Regeneron Phars, Inc 纽约州塔里克镇和巴黎2022年2月18日电 /美通社/ -- 在一项针对奥马珠单抗难治性患者的3期试验中，尽管在关键终点上观察到数字上的改善，但Dupixent在中期分析中未达到统计学意义；试验将因�荇藻荌惜謘C 之前在生物制剂�荇覺w者中进行的一项3期试验的积极结果显示，与单独使用标准抗组胺药相比，Dupixent能显著减少瘙痒和荨麻疹。 公司仍致力于推动Dupixent用于抗组胺药�茠k控制的慢性自发性荨麻疹患者，并正在评估下一步行动。 Regeneron制药公司（纳斯达克：REGN）和赛诺菲公司今天宣布，根据预先指定的中期分析，评估Dupixent®（dupilumab）对慢性自发性荨麻疹（CSU）患者的3期试验（CUPID STUDY B）将因�荇藻荌惜謘C该试验评估了对奥马珠单抗难治的患者在24周内将Dupixent添加到抗组胺药物中，在减少瘙痒和荨麻疹（主要终点）方面显示出积极的数字趋势，但在独立审查委员会进行的中期分析中没有达到统计意义。安全性数据与Dupixent在其批准的适应症中的已知安全性特征基本一致。 LIBERTY-CUPID枢轴项目于2020年启动，采取了加速直接进入3期的策略。之前报道的3期试验评估了不同的生物制剂�荇覺w者群体（即之前没有接受过奥马珠单抗治疗），在24周时达到了其主要和所有关键的次要终点，表明与单独使用抗组胺药物相比，在标准护理抗组胺药物中添加Dupixent可显著减少瘙痒和荨麻疹。两家公司仍然致力于推动Dupixent用于使用抗组胺药�茠k控制的CSU患者，并正在评估下一步行动。 Regeneron公司总裁兼首席科学官George D. Yancopoulos博士说：慢性自发性荨麻疹是一种非常复杂的疾病，这些数据增加了评估疾病负担潜在驱动因素的证据，包括白细胞介素4和白细胞介素13的潜在作用。虽然Dupixent在对所有获批药物仍难治好的最难治好的病人身上没有显示出明显的好处，但我们正在仔细评估Dupixent在CSU中的潜在作用，这是基于在生物制剂�荇蘆滲f人身上进行的第一个3期试验的成功，Dupixent使瘙痒和荨麻疹活动的减少几乎翻了一番。 第一次试验的详细结果将在本月晚些时候的AAAAI年会上公布，两家公司预计将在一个科学论坛上分享第二次试验的结果。Regeneron和赛诺菲正在迅速推进一项广泛的临床开发计划，以评估Dupixent在有重大未满足需求的疾病中的作用，以及2型炎症可能发挥的作用。这两家公司最近还宣布了嗜酸细胞性食管炎（EoE）和结节性瘙痒症（PN）的3期阳性结果，预计今年晚些时候在小儿EoE、慢性诱导性荨麻疹-感冒（CindU）和手足异位性皮炎方面也会有更多结果。 |
