PARSIPPANY, N.J. & PARIS--(BUSINESS WIRE)--Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Sanofi today announced an update to the timing for the anti-TL1A, duvakitug (formerly known as TEV-’574/SAR447189) program investigating the human IgG1-λ2 monoclonal antibody targeting TL1A for moderate-to-severe IBD..

新泽西州帕西帕尼（PARSIPPANY）和巴黎（BUSINESS WIRE）--Teva Pharmaceuticals，Teva Pharmaceuticals Industries Ltd.（纽约证券交易所和塔斯社：Teva）的美国附属公司和赛诺菲（Sanofi）今天宣布了抗TL1A duvakitug（以前称为TEV-'574/SAR447189）计划的时间更新，该计划研究针对中重度IBD的TL1A的人IgG1-λ2单克隆抗体。。

Patient enrollment in the RELIEVE UCCD (ulcerative colitis and Crohn’s disease) Phase 2b trial has completed early due to significant acceleration in patient recruitment. As a result, Teva and Sanofi now anticipate having topline results for both UC and CD in Q4 2024, and detailed results will be presented in a scientific forum in 2025.

由于患者招募的显着加速，缓解UCCD（溃疡性结肠炎和克罗恩病）2b期试验的患者登记已经提前完成。因此，Teva和赛诺菲现在预计2024年第四季度UC和CD的最终结果，详细结果将在2025年的科学论坛上公布。

This adjustment replaces the previously planned interim analysis for the second half of 2024, which will not be conducted. Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug for moderate-to-severe UC and CD patients..

这一调整取代了之前计划的2024年下半年中期分析，该中期分析将不再进行。Teva和赛诺菲正在合作为中重度UC和CD患者共同开发duvakitug并将其商业化。。

On October 3, 2023, Teva and Sanofi entered into an exclusive collaboration to co-develop and co-commercialize Teva’s duvakitug (anti-TL1A) for the treatment of UC and CD, two types of IBD. Under the terms of the agreement, in partial consideration of licenses granted to Sanofi, Teva received an upfront payment of $500 million shortly after closing and may receive up to $1 billion in development and launch milestones.

2023年10月3日，特瓦和赛诺菲达成独家合作，共同开发和共同商业化特瓦的duvakitug（抗TL1A），用于治疗UC和CD（两种类型的IBD）。根据协议条款，在部分考虑到授予赛诺菲的许可证后，特瓦在交割后不久收到了5亿美元的预付款，并且可能会收到高达10亿美元的开发和启动里程碑。

Each company will equally share the remaining development costs globally and net profits and losses in major markets, with other markets subject to a royalty arrangement. Sanofi will lead the development of the Phase 3 program. Teva will lead commercialization of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia and the rest of the world..

每家公司将在全球范围内平均分担剩余的开发成本以及主要市场的净损益，其他市场则需遵守特许权协议。赛诺菲将领导第三阶段项目的开发。Teva将在欧洲、以色列和指定的其他国家领导产品的商业化，赛诺菲将在北美、日本、亚洲其他地区和世界其他地区领导商业化。。

About Inflammatory Bowel Disease

关于炎症性肠病

Inflammatory bowel disease (IBD) is a chronic autoimmune disorder characterized by chronic inflammation of the gastrointestinal (GI) tract. The two main types of IBD are ulcerative colitis (UC) and Crohn’s disease (CD).1 UC and CD are chronic inflammatory conditions of the GI tract characterized by repetitive cycles of relapses and remission.

炎症性肠病（IBD）是一种慢性自身免疫性疾病，其特征在于胃肠道（GI）的慢性炎症。IBD的两种主要类型是溃疡性结肠炎（UC）和克罗恩病（CD）。UC和CD是胃肠道的慢性炎症，其特征在于复发和缓解的重复周期。

Prolonged inflammation can lead to damage within the GI tract, including fibrosis, a common complication of IBD characterized by an excessive accumulation of scar tissue in the intestinal wall, which may cause narrowing and obstruction. Common symptoms of both conditions include persistent diarrhea, rectal bleeding, abdominal pain, loss of appetite, and weight loss.

长期炎症可导致胃肠道损伤，包括纤维化，这是IBD的常见并发症，其特征在于肠壁瘢痕组织过度积聚，这可能导致狭窄和阻塞。这两种情况的常见症状包括持续性腹泻，直肠出血，腹痛，食欲不振和体重减轻。

About RELIEVE UCCD

关于解除UCCD

RELIEVE UCCD is a 14-week Phase 2b, randomized, double-blind, dose-ranging study to determine the pharmacokinetics, efficacy, safety, and tolerability of duvakitug (anti-TL1A) in adults with ulcerative colitis (UC) or Crohn's disease (CD). In the trial, patients who meet pre-specified inclusion criteria are randomized to subcutaneously receive either one of two duvakitug (anti-TL1A) dose regimens or placebo in a 1:1:1 ratio (stratified by diagnosis [UC or CD] and previous exposure to advanced IBD therapy [biologics and small molecules]) for 14 weeks.

Release UCCD是一项为期14周的2b期随机双盲剂量范围研究，旨在确定duvakitug（抗TL1A）在成人溃疡性结肠炎（UC）或克罗恩病（CD）中的药代动力学，疗效，安全性和耐受性。在该试验中，符合预先规定的纳入标准的患者被随机分配到皮下接受两种duvakitug（抗TL1A）剂量方案或安慰剂中的一种，比例为1:1:1（按诊断[UC或CD]分层）和先前暴露于晚期IBD治疗[生物制剂和小分子]）14周。

Participants who complete the 14-week induction period have the option to enter the long-term extension (LTE), consisting of a 44-week maintenance period for responders and a re-induction period for non-responders. Primary efficacy endpoints for both the 14-week and 44-week LTE study are number of participants with moderate-to-severe UC who show clinical remission (as defined by the modified Mayo score) and the number of participants with moderate-to-severe CD who show an endoscopic response (as defined by the endoscopic score for CD).

完成14周诱导期的参与者可以选择进入长期延长（LTE），包括44周的响应者维护期和无响应者的重新诱导期。14周和44周LTE研究的主要疗效终点是中度至重度UC患者的临床缓解人数（由改良的梅奥评分定义）和中度至重度CD患者的内镜反应（由CD的内镜评分定义）。

The trial includes sites in the U.S., Canada, Europe, and Asia.4,5.

该试验包括美国，加拿大，欧洲和亚洲的网站。

About Duvakitug (Anti-TL1A)

关于Duvakitig（抗TL1A）

Duvakitug (anti-TL1A) is a potential best-in-class human IgG1-λ2 monoclonal antibody that targets tumor necrosis factor (TNF)-like ligand 1A (TL1A), also known as TNF superfamily member 15 (TNFSF15). TL1A signaling is believed to amplify inflammation and drives fibrosis associated with inflammatory bowel disease (IBD); thus, targeting TL1A with duvakitug may mitigate the over-active immune response in these conditions.

Duvakitug（抗TL1A）是一种潜在的同类最佳的人IgG1-λ2单克隆抗体，靶向肿瘤坏死因子（TNF）样配体1A（TL1A），也称为TNF超家族成员15（TNFSF15）。TL1A信号传导被认为会放大炎症并驱动与炎症性肠病（IBD）相关的纤维化；因此，用duvakitug靶向TL1A可以减轻这些情况下过度活跃的免疫反应。

Duvakitug (anti-TL1A) is currently in Phase 2b clinical trials for the treatment of ulcerative colitis (UC) and Crohn's disease (CD), two types of inflammatory bowel disease. The safety and efficacy of duvakitug (anti-TL1A) have not been reviewed by any regulatory authority..

Duvakitug（抗TL1A）目前正在进行2b期临床试验，用于治疗溃疡性结肠炎（UC）和克罗恩病（CD），这两种炎症性肠病。。。

About Teva

关于Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicines. For over 120 years, Teva's commitment to bettering health has never wavered.

Teva Pharmaceutical Industries Ltd.（纽约证券交易所和塔斯社：Teva）是一家全球制药领导者，拥有挑战类别的投资组合，利用我们的仿制药专业知识并加强创新，以继续推动现代药物的发现，交付和扩展开发。120多年来，特瓦对改善健康的承诺从未动摇过。

Today, the company’s global network of capabilities enables its 37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com..

如今，该公司的全球能力网络使其在58个市场的37000名员工能够突破科学创新的界限，提供优质药物，帮助每天改善数百万患者的健康状况。要了解更多关于Teva如何改善健康的信息，请访问www.tevapharm.com。。