A Phase 2, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate-to-severe Ulcerative Colitis

This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis.
This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment.
Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants.
* The study duration will be up to 59 weeks.
* The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm.
* The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.

开始日期2025-03-28

申办/合作机构

Sanofi

NCT06637631

/ Recruiting临床2期

A Phase 2, Multinational, Multicenter, Randomized, Doubleblind, Placebocontrolled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Crohn's Disease.

This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD.
This study will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks. The MS period include a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance. At the end of 52 weeks in the MS period, eligible participants from MS period will be offered a Double-Blind Maintenance Extension (DBME) period for up to 52 weeks.
Additionally, an Open Label (OL) period of up to 92 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 92 weeks, while the sum of the DBME and OL periods may not exceed 52 weeks, depending on when participants switch.

开始日期2024-12-10

申办/合作机构

Sanofi

100 项与 Balinatunfib 相关的临床结果

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100 项与 Balinatunfib 相关的转化医学

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100 项与 Balinatunfib 相关的专利（医药）

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项与 Balinatunfib 相关的文献（医药）

2025-07-18·ChemMedChem

Balinatunfib: A Clinical Oral Small Molecule TNFα Inhibitor

Article

作者: Dömling, Alexander ; Holak, Tad A.

Most diseases are accompanied by an inflammatory response, making effective pharmacological control highly desirable. Tumor necrosis factor alpha (TNFα) is a key cytokine driving inflammatory and autoimmune diseases, such as rheumatoid arthritis and inflammatory bowel disease. Although biological TNFα inhibitors revolutionized treatment, they have drawbacks including lacking blood–brain barrier penetration, parenteral administration, and immunogenicity. Recent studies highlight the potential of small‐molecule approaches to target TNFα by stabilizing an asymmetrical, receptor‐incompetent trimer conformation. Balinatunfib (also known as SAR441566) is an orally available small molecule designed to exploit this mechanism, thereby preventing TNFα from effectively binding to its receptors. In preclinical models, balinatunfib reduces inflammation comparably to biologic therapies, yet avoids the complexities of large protein therapeutics. This allosteric strategy involves capturing a sampled but distorted state of TNFα, thereby blocking receptor clustering and downstream proinflammatory signaling. The oral route of administration confers practical advantages in terms of patient compliance and could facilitate drug access to sites traditionally less amenable to biologics, such as the central nervous system. By demonstrating that small molecules can achieve high‐affinity, conformation‐based inhibition of TNFα, balinatunfib, and related compounds may result in a new area of orally administered therapies that advance the management of TNFα‐mediated diseases.

2025-07-01·CLINICAL PHARMACOLOGY & THERAPEUTICS

First‐in‐Human Single and Multiple Ascending Dose Studies of Balinatunfib, a Small Molecule Inhibitor of TNFR1 Signaling in Healthy Participants

Article

作者: Rharbaoui, Faiza ; Rehberg, Markus ; Lahmar, Amel ; Wagner, Frank‐Dietrich ; Wiekowski, Maria ; Kohlmann, Markus ; Nguyen, Mai Anh ; Gassenhuber, Johann ; Kovar, Andreas ; Nassr, Nassr ; Perrin, Laurent ; Weitz, Dietmar ; Schumacher, Fabienne

Oral small molecule inhibitors of tumor necrosis factor alpha (TNFα) are emerging as attractive therapeutic agents for the treatment of various autoimmune diseases. Balinatunfib (SAR441566), a novel oral inhibitor of tumor necrosis factor receptor 1 (TNFR1) signaling, changes the configuration of the soluble TNFα (sTNFα) trimer and prevents its heterotrimerization with TNFR1 but not TNFR2, thereby blocking TNFR1 signaling. Herein, we report the results from a first‐in‐human (FIH) study that evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) following single ascending doses (SAD) and multiple ascending doses (MAD) of balinatunfib in healthy male participants. Single (5–600 mg) and multiple (100–600 mg total daily dose for up to 14 days) oral doses of balinatunfib were well‐tolerated in all participants. Consistent PK data were obtained across the studies, with a median tmax of 2.5–5 hours, a mean terminal half‐life of 22–30 hours, and a time to steady state of 5–6 days. A supra‐proportional exposure increase was observed in both SAD and MAD studies, which was less pronounced at doses ≥ 180 mg. Food had no relevant effects on the PK characteristics of balinatunfib. As the main PD read‐out, complete TNFα occupancy was shown at all tested time points after the treatment started. Balinatunfib, as the first clinically tested oral TNFR1 signal inhibitor, demonstrated a good safety profile along with favorable PK/PD characteristics that allowed both once and twice daily dosing, confirming a successful preclinical‐to‐clinical translation and guiding dose selection for further clinical efficacy studies.

Frontiers in pharmacology

An orally available small molecule that targets soluble TNF to deliver anti-TNF biologic-like efficacy in rheumatoid arthritis

Article

作者: Wright, Sara ; Zhu, Zhaoning ; Schio, Laurent ; Leeuw, Thomas ; Bourne, Tim ; Heer, Jag ; Foricher, Yann ; Verbitsky, Alexander ; Stanley, Phil ; Herrmann, Matthias ; Nicholas, Jean-Marie ; Rao, Srinivas ; Ying, Xiaoyou ; O'Connell, James ; Carrington, Bruce ; Rehberg, Markus ; Brookings, Daniel ; Nguyen, Mai Anh ; Kohlmann, Markus ; Moss, Andrew ; Hickford, Elizabeth ; Vugler, Alexander ; Merriman, Mark ; Weitz, Dietmar ; Horsley, Helen ; Florian, Peter

Tumor necrosis factor (TNF) is a pleiotropic cytokine belonging to a family of trimeric proteins with both proinflammatory and immunoregulatory functions. TNF is a key mediator in autoimmune diseases and during the last couple of decades several biologic drugs have delivered new therapeutic options for patients suffering from chronic autoimmune diseases such as rheumatoid arthritis and chronic inflammatory bowel disease. Attempts to design small molecule therapies directed to this cytokine have not led to approved products yet. Here we report the discovery and development of a potent small molecule inhibitor of TNF that was recently moved into phase 1 clinical trials. The molecule, SAR441566, stabilizes an asymmetrical form of the soluble TNF trimer, compromises downstream signaling and inhibits the functions of TNF in vitro and in vivo. With SAR441566 being studied in healthy volunteers we hope to deliver a more convenient orally bioavailable and effective treatment option for patients suffering with chronic autoimmune diseases compared to established biologic drugs targeting TNF.

项与 Balinatunfib 相关的新闻（医药）

2025-08-01

·赛诺菲中国

8月临床试验信息速递

中重度溃疡性结肠炎（UC）和克罗恩病的治疗研究新进展疾病背景与全球研发进展溃疡性结肠炎是一种慢性、进展性疾病，其特征是局限于结肠的弥漫性黏膜炎症。克罗恩病是一种慢性、进行性免疫介导的胃肠道疾病。炎症是由免疫反应失调导致的，导致一系列炎症细胞和促炎性细胞因子（例如，TNFα），损伤并破坏从口腔到肛门的胃肠道黏膜的浅层和深层。TNFα拮抗剂是 CD 治疗的标志性药物之一，通常被各种胃肠病学会推荐用作一线治疗，以促使疾病缓解。SAR441566/Balinatunfib 是一种可溶性 TNFα 信号的小分子抑制剂，可与可溶性 TNFα 三聚体中心的口袋结合, 抑制三聚体 TNFα通过其主要受体 TNFR1 的信号传导，同时保留通过 TNFR2 的信号传导，进而减少对人体自身组织的自身免疫应答并降低感染风险。目前Balinatunfib正在开展相关的临床试验，以探索其在中重度克罗恩病的应用潜力。中国研发进展赛诺菲正积极推进Balinatunfib在中国的临床开发。赛诺菲中国研发团队与全球项目组保持着紧密的合作关系，致力于加速包括 Balinatunfib在内的一些特殊药物组合在中国的研发进程。在赛诺菲中国研发团队的努力下，中国患者有望更早地参与到全球同步的临床试验中。一项在中重度溃疡性结肠炎成人患者中评价 SAR441566 的疗效和安全性的 Ⅱ 期、国际多中心、随机、双盲、安慰剂对照、剂量范围探索研究，正在全球多个国家开展（中国国家药品监督管理局批准通知书号：2025LP01429）。中国计划在10家研究中心招募15例成人受试者。一项在成年中重度克罗恩病患者中评价 SAR441566 的疗效和安全性的 Ⅱ 期、国际多中心、随机双盲、安慰剂对照、剂量范围探索研究正在全球多个国家开展（中国国家药品监督管理局批准通知书号: 2024LP03047）。中国计划在12家中心招募15例受试者。鼻窦炎伴或不伴鼻息肉的治疗研究新进展疾病背景与全球研发进展鼻窦炎是一种常见的上呼吸道炎症性疾病，当伴有鼻息肉时，患者症状往往会更为严重。Itepekimab是一种完全人源化的单克隆抗体，能够特异性结合并抑制白介素-33(这是一种在多种炎症性疾病中起到引发和放大作用的关键因子，以下称“IL-33”）。通过阻断IL-33通路，有望减轻鼻腔和鼻窦炎症，改善患者呼吸功能和生活质量。目前，Itepekimab正在开展相关的临床试验，以探索其在鼻窦炎伴或不伴鼻息肉中的应用潜力。中国研发进展赛诺菲正积极推进Itepekimab在中国的临床开发。赛诺菲中国研发团队与全球项目组保持着紧密的合作关系，致力于加速包括 Itepekimab 在内的一些特殊药物组合在中国的研发进程。在赛诺菲中国研发团队的努力下，中国患者有望更早地参与到全球同步的临床试验中。一项在控制不佳的慢性鼻窦炎伴鼻息肉成人参与者中评价itepekimab的疗效、安全性和耐受性的随机、双盲、安慰剂对照、平行组、52周III期试验正在全球多个国家开展（中国国家药品监督管理局批准通知书号: 2025LP00343）。中国计划在约15家中心招募33例受试者。一项评估Itepekimab在控制不佳的慢性鼻窦炎不伴鼻息肉参与者中的疗效、安全性和耐受性的随机、双盲、安慰剂对照、概念验证（PoC）研究（正在全球多个国家开展（中国国家药品监督管理局批准通知书号: 2025LP00140）。中国计划在约4家中心招募4例受试者。中重度特应性皮炎（AD）的治疗研究新进展疾病背景与全球研发进展特应性皮炎是一种慢性／复发性炎症性皮肤病，表现为剧烈瘙痒和复发性湿疹样皮损。目前的证据表明，过于活跃的 OX40 配体（OX40L）／OX40 通路在疾病发病机制中发挥着重要作用。Amlitelimab是一种人抗OX40L免疫球蛋白 G4（IgG4）单克隆抗体（mAb），预期可通过阻断 OX40／OX40L 通路来抑制 Th2 细胞驱动的炎症以及潜在抑制 Th1、Th17、Th22 反应。目前，Amlitelimab正在开展相关的临床试验，以探索其在中重度特应性皮炎患者中的应用潜力。中国研发进展赛诺菲正积极推进Amlitelimab在中国的临床开发。赛诺菲中国研发团队与全球项目组保持着紧密的合作关系，致力于加速包括 Amlitelimab 在内的一些特殊药物组合在中国的研发进程。在赛诺菲中国研发团队的努力下，中国患者有望更早地参与到全球同步的临床试验中。一项评价以外用糖皮质激素为背景治疗且对既往生物治疗或口服 JAK 抑制剂治疗反应不充分的 12 岁及以上中重度 AD 受试者皮下接受 amlitelimab 治疗的疗效和安全性的研究,正在全球多个国家开展（中国国家药品监督管理局批准通知书号: 2024LP01122，2024LP01123）。中国计划在约13家中心招募至少22例受试者（含青少年受试者）。“高风险”（高FeNO, 高嗜酸）哮喘的治疗研究新进展疾病背景与全球研发进展哮喘是一种常见的慢性气道炎症性疾病，而对于高 FeNO和高血嗜酸性粒细胞计数确定的 2 型炎症增加的高风险哮喘患者，目前维持治疗常常无法有效控制症状、急性发作或肺功能受损。Lunsekimig 是一种靶向TSLP和IL-13的纳米抗体分子，靶向 TSLP（吸入性过敏原、刺激物或病原体引发气道反应的上游启动因子）和 IL-13（侵入物引发气道反应的下游介导和增强因子）旨在抑制哮喘反应的启动和增强。Lunsekimig通过双重阻断 TSLP和IL-13，有望防止哮喘急性发作和肺功能受损，从而改善患者呼吸功能和生活质量。目前，Lunsekimig正在开展相关的临床试验，以探索其在成人高风险哮喘中的应用潜力。中国研发进展赛诺菲中国研发团队与全球项目组保持着紧密的合作关系，致力于加速Lunsekimig在中国的研发进程。在赛诺菲中国研发团队的努力下，该创新疗法惠及中国患者，与全球的治疗方案同步。一项在目前不适合接受生物治疗的高风险哮喘成人受试者中研究皮下注射 lunsekimig（SAR443765）的有效性、安全性和耐受性的随机、双盲、安慰剂对照、平行分组、双臂的 II 期研究正在全球多个国家开展（中国国家药品监督管理局批准通知书号: 2024LP02543）。中国计划在约40家中心招募26例受试者。未控制的中重度哮喘成人患者的治疗研究新进展疾病背景与全球研发进展哮喘是一种慢性炎症性呼吸系统疾病，表现为多变且可逆的气道阻塞，并可能出现肺功能经时下降。肺功能下降可能是伴随哮喘基础病理变化气道壁炎症反应出现的气道结构变化所致，肺功能下降与疾病的发病率和死亡率增加有关。度普利尤单抗是一种靶向白细胞介素 4 受体 α（IL-4Rα）亚单位的全人源单克隆抗体，其组成成分是 IL-4 受体 I 型（仅 IL-4 配体）和 II 型（IL-4 和 IL-13 配体）的异构二聚体。度普利尤单抗与 IL-4Rα 结合能阻断 IL-4 和 IL-13 启动的下游信号传导。这些细胞因子在哮喘发病机制中发挥关键和核心作用。目前，度普利尤单抗／达必妥®正在开展相关的临床试验，以探索其在未控制的中重度哮喘患者中预防肺功能下降长期疗效的应用潜力。中国研发进展赛诺菲中国研发团队与全球项目组保持着紧密的合作关系，致力于加速度普利尤单抗／达必妥®在中国的研发进程。在赛诺菲中国研发团队的努力下，该疗法有望惠及中国患者，与全球治疗方案同步。一项在未控制的中重度哮喘患者中评价度普利尤单抗预防肺功能下降长期疗效的随机、双盲、安慰剂对照研究（ATLAS）正在全球多个国家开展（中国国家药品监督管理局批准通知书号: 2024LP02138）。中国计划在约25家中心招募60例受试者。中国速度赛诺菲中国研发团队正与全球项目组紧密合作，以推动这些创新疗法尽快惠及中国患者。通过全球与中国的同步研发策略，赛诺菲致力于缩短创新药物在中国的可及性时间差，为中国患者带来世界领先的治疗方案。注：本文提及的部分适应症尚处于临床研究阶段。如需了解更多信息，请咨询专业医疗人员。如有意参加相关临床试验，请联系contact-us.cn@sanofi.com，并提供您的所在城市，我们会为您就近推荐适合的研究中心。向上滑动了解更多关于赛诺菲中国赛诺菲是一家研发驱动、AI 赋能的生物制药公司，致力于焕发生命光彩并实现强劲增长。作为改革开放后首批进入中国的跨国企业之一，赛诺菲于1982年便在中国建立了办公室，目前拥有从研发、生产制造到商业运营的端到端价值链，包括3家生产基地和4大研发基地，业务覆盖制药和疫苗。赛诺菲与中国同心同行，致力于将创新药品和疫苗加速引进中国，造福更多中国百姓，也为合作伙伴、社区和员工创造更美好的生活。如需了解更多信息，请访问www.sanofi.cn ，或关注“赛诺菲中国”微信公众号。关于赛诺菲赛诺菲是一家研发驱动、AI 赋能的生物制药公司，致力于焕发生命光彩并实现强劲增长。凭借对免疫系统的深刻理解，我们研发的药物和疫苗为全球数百万民众提供治疗与守护，我们的创新管线有望惠及更广泛人群。我们秉持共同的使命：追求科学奇迹，焕发生命光彩；它激励我们锐意进取，全力应对当今时代最紧迫的医疗、环境和社会挑战，为我们所服务的人和社区带来积极影响。赛诺菲前瞻性声明本新闻稿包含1995年修订的《私人证券诉讼改革法案》中定义的前瞻性声明。前瞻性声明并非对历史事实的陈述。这些声明包括这些声明包括预测和估计以及其基础假设，涉及未来财务结果、事件、运营、服务、产品开发和潜力的计划、目标、意图和期望的陈述，以及与未来业绩相关的陈述。通常可以利用诸如“期望”、“预期”、“相信”、“打算”、“估计”、“计划”等词语，以及类似表达作为判定前瞻性声明的依据。尽管赛诺菲管理层认为该篇前瞻性声明中所反映的预期具有合理性，投资者仍需注意这些前瞻性信息和声明受制于诸多风险和不确定性因素，其中许多难以预测且通常不被赛诺菲所控制，这可能导致实际结果和发展与前瞻性信息和陈述中所表达、暗示或预测的信息存在重大差异。这些风险和不确定因素包括但不限于：研究和开发中固有的不确定因素，未来的临床数据和分析，包括产品上市后所获取的数据和所进行的分析，美国食品和药品监督管理局（FDA）或欧洲药品管理局（EMA）等监管机构对任何药物、器械或生物制品申请是否以及何时批准的决定，以及对标签和其他可能影响该类候选产品可得性或商业潜力的事项的决定，批准的候选产品可能商业上不成功的事实，替代性疗法的未来批准和商业成功，赛诺菲从外部增长机会中受益，完成相关交易和/或获得监管批准的能力，续与知识产权相关的待决或未来诉讼和这种诉讼的最终结果有关的风险，汇率和利率的趋势，以及波动的经济和市场条件，成本控制措施及其后续变化，以及流行病或其他全球危机可能给我们、客户、供应商和其他业务合作伙伴以及任何一方的财务状况带来的影响，也包括对我们的员工和全球经济带来的影响。这些风险和不确定性也包括赛诺菲在公开呈报给美国证券交易委员会（SEC）和法国金融市场管理局（AMF）的报告中已作讨论或明确的部分，其中包括列于表20-F的赛诺菲年度报告（截止日期2024年12月31日）中的“风险因素”和“前瞻性声明警示”。除非存在可适用的法律规定，赛诺菲不承担更新和修改任何前瞻性信息和陈述的义务。

临床2期

2025-07-31

·EndPoints

Sanofi rides Dupixent sales wave, but profits fall short

Sanofi has inched up its full-year guidance after another quarter of strong sales for its Regeneron-partnered drug Dupixent, which the French drugmaker said was catapulted by its recent launch in a chronic lung disease. But its earnings per share of €1.59 missed Wall Street analyst expectations of €1.65, Jefferies analysts wrote. While sales were strong, profits took a hit due to higher operating expenses. The company’s shares were down around 2% on the Paris exchange at market open. Dupixent hit €3.8 billion ($4.3 billion) in sales, up 21% from the same time last year. Sanofi now expects full-year 2025 sales to grow in the high single-digit percentage range, compared to a prior range of mid- to high single-digit growth. Its total Q2 sales increased 10% to €9.9 billion ($11.3 billion). “It is really impressive to see that Dupixent keeps on growing even in the first indications like atopic dermatitis and asthma, which were launched eight years ago,” Sanofi CFO François Roger said on an earnings call with the media. He added that “we are very confident in our set target of around €22 billion in 2030.” Dupixent’s patents are set to start expiring in the early to mid-2030s. The immunology drug secured a US label expansion for chronic obstructive pulmonary disease (COPD) in September 2024. It has since been launched for the disease in eight countries. Global Dupixent sales were strong in the quarter, but were “partially offset” by some weakness in China due to the renewal of the country’s national reimbursement drug list. “We do experience regular price decreases [in China], which are more than largely compensated by very significant volume prices, which is exactly the case as far as COPD is concerned,” Roger said. He added that Sanofi’s growth “goes beyond just Dupixent.” Last week, the company’s CD38-targeting drug Sarclisa clinched an EU label expansion for newly-diagnosed multiple myeloma patients who are eligible for autologous stem cell transplant. Sarclisa sales increased 19% to €140 million in the quarter. Sanofi also won a US label expansion in May for its meningitis vaccine MenQuadfi to protect infants as young as 6 weeks old. But the drugmaker has had a bumpier ride on the pipeline side in the first half of the year. In May, its Regeneron-partnered IL-33 antibody itepekimab passed one Phase 3 trial in COPD but flunked a second . Another inflammatory disease candidate, called amlitelimab, failed a Phase 3 study in asthma the month before. The company also previously reported a Phase 2 disappointment for its oral TNF inhibitor, balinatunfib, in psoriasis. “As a science-focused company, we know that setbacks are a part of the R&D process, so it’s a normal situation,” Roger said. “Our pipeline is diverse, both in terms of acquisition and our own development, which means that we are not exposed to one single asset at the end.” Meanwhile, Roger also said that Sanofi is “committed” to working with the Trump administration to lower “prices for patients at the pharmacy counter.” But he added that “real impact will come from fixing inefficiencies” and “price controls are not the right solution for patients or science.” The CFO said that the company is also considering direct-to-patient sales in the US as a way of improving drug affordability. His comments echo those of AstraZeneca CEO Pascal Soriot and Roche CEO Thomas Schinecker .

临床3期上市批准临床结果生物类似药

2025-05-30

·FierceBiotech

Sanofi, Regeneron\'s IL-33 drug fails one of 2 COPD studies as FDA timeline thrown in doubt

Sanofi said it will take itepekimab data to regulators to \"evaluate our path forward.\"\n Sanofi’s plans to submit itepekimab to regulators for approval this year have been thrown into doubt after the Regeneron-partnered drug failed one of a pair of phase 3 chronic obstructive pulmonary disease (COPD) trials.Both of the studies, dubbed Aerify-1 and Aerify-2, evaluated administering the IL-33 drug itepekimab subcutaneously every two weeks or four weeks across a combined total of more than 2,000 former smokers with moderate to severe COPD. Both trials were designed to demonstrate a statistically significant reduction in moderate or severe exacerbations of COPD compared to placebo after 52 weeks.Aerify-1 hit this endpoint by demonstrating a 27% relative reduction in exacerbations among patients who received itepekimab every two weeks and a 21% reduction among those who received the drug every four weeks.But Aerify-2 was less successful, producing just a 2% reduction at two-week dosing and a 12% reduction at four-week dosing.Sanofi partly blamed the results on the lower total number of exacerbations “than prospectively anticipated,” which the company said had “decreas[ed] the power of both trials.”“Enrollment largely occurred during the time of the global COVID pandemic, which could have contributed to the overall lower exacerbation rates,” the pharma explained.Adverse events were “generally comparable” between the itepekimab and placebo cohorts, Sanofi said in its May 30 release. In the failed Aerify-2 trial, adverse events that led to death were 3% for each of the itepekimab cohorts compared to 2% for the placebo group.The failure of that trial is a significant setback for a drug that was listed in Sanofi’s most recent earnings presentation in April as being lined up for a regulatory filing in the second half of this year. At the time, Houman Ashrafian, Ph.D., Sanofi’s head of R&D, described the COPD readouts as “significant” and told analysts they could potentially lead to itepekimab’s market launch in 2026.In a statement attached to this morning’s data, Ashrafian sounded more muted on the drug’s near-term plans.“While we are encouraged by the results of AERIFY-1, the results of both studies merit further exploration to have a full understanding of the data and the role that IL-33 plays in this complex disease,” Ashrafian said. “Certain people with COPD are in desperate need of new treatment options, especially those who continue to experience exacerbations despite being on maximal therapy, and we remain committed to discussing these data with regulatory agencies to evaluate our path forward.”Sanofi declined to confirm to Fierce Biotech that its previous FDA timeline remains on track. The French Big Pharma had been developing itepekimab in collaboration with Regeneron. The two companies have seen blockbuster success with their immunology drug Dupixent and had previously evaluated the two therapies in combination as an asthma treatment in a phase 2 trial before halting that work in 2021. Separate phase 2 and 3 trials of itepekimab in COPD remain ongoing. Even if today’s unimpressive results mark the end of the road for itepekimab in that respiratory indication, the drug is still being evaluated in trials for rhinosinusitis with nasal polyps and bronchiectasis.“We are encouraged by the initial results from AERIFY-1 and are carefully reviewing the results from both itepekimab trials to inform next steps,” Regeneron Chief Scientific Officer George Yancopoulos, M.D., Ph.D., said in today’s release.“We remain committed to our broader itepekimab development program,” Yancopoulos added. “The learnings will be invaluable as we continue to advance itepekimab in respiratory diseases with unmet need.”The Aerify-2 fail continues a run of bad luck for Sanofi this year. The Paris-based pharma has also seen its psoriasis drug balinatunfib, its asthma hopeful amlitelimab and its Johnson & Johnson-sourced E. coli vaccine all underwhelm in the clinic in 2025.

$Sanofi, Regeneron\'s IL-33 drug fails one of 2 COPD studies as FDA timeline thrown in doubt$

临床2期临床3期疫苗临床结果

100 项与 Balinatunfib 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
溃疡性结肠炎	临床2期	美国	Sanofi	2025-03-28
溃疡性结肠炎	临床2期	中国	Sanofi-Aventis Recherche & Développement SA	2025-03-28
溃疡性结肠炎	临床2期	日本	Sanofi	2025-03-28
溃疡性结肠炎	临床2期	阿根廷	Sanofi	2025-03-28
溃疡性结肠炎	临床2期	澳大利亚	Sanofi	2025-03-28
溃疡性结肠炎	临床2期	比利时	Sanofi	2025-03-28
溃疡性结肠炎	临床2期	加拿大	Sanofi	2025-03-28
溃疡性结肠炎	临床2期	智利	Sanofi	2025-03-28
溃疡性结肠炎	临床2期	捷克	Sanofi	2025-03-28
克罗恩病	临床2期	美国	Sanofi	2024-12-10

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06073119 (SPECIFI-PSO, NEWS) 人工标引	临床2期	银屑病	221	balinatunfib	鬱築鬱網衊鏇遞鹽窪壓(願醖願鏇鑰餘憲衊網繭) = statistically no better than placebo 餘鬱糧獵願觸簾繭繭顧 (鏇範蓋積觸衊顧醖廠獵 ) 未达到	不佳	2025-04-24
				Placebo