Teva and Sanofi Accelerate Anti-TL1A Phase 2b Program for Inflammatory Bowel Disease

Teva Pharmaceuticals, a U.S. subsidiary of Teva Pharmaceutical Industries Ltd., and Sanofi have announced an updated timeline for their anti-TL1A, duvakitug (formerly known as TEV-’574/SAR447189) program, which investigates a human IgG1-λ2 monoclonal antibody targeting TL1A for moderate-to-severe inflammatory bowel disease (IBD). The announcement was made on July 25, 2024, from PARSIPPANY, NJ, USA & PARIS, France.

The RELIEVE UCCD (ulcerative colitis and Crohn’s disease) Phase 2b trial, which is a part of this program, has completed patient enrollment earlier than planned due to accelerated recruitment rates. Consequently, Teva and Sanofi now expect to obtain topline results for both ulcerative colitis (UC) and Crohn’s disease (CD) by the fourth quarter of 2024. Detailed findings will be shared in a scientific forum in 2025. This change means that the initially planned interim analysis for the latter half of 2024 will no longer take place. The two companies are jointly developing and planning to co-market duvakitug for patients with moderate-to-severe UC and CD.

This collaboration began on October 3, 2023, when Teva and Sanofi entered an exclusive agreement to co-develop and co-commercialize duvakitug. According to the terms, Teva received an upfront payment of $500 million and may receive up to an additional $1 billion upon achieving certain development and launch milestones. The companies will equally share the remaining global development costs and net profits and losses in major markets. Sanofi will oversee the development of the Phase 3 program, while Teva will manage the commercialization in Europe, Israel, and specified other regions. Sanofi will lead the commercialization efforts in North America, Japan, other parts of Asia, and the rest of the world.

Inflammatory bowel disease (IBD) is a chronic autoimmune disorder causing persistent inflammation in the gastrointestinal (GI) tract. The primary types of IBD are ulcerative colitis (UC) and Crohn’s disease (CD). Both conditions are marked by cycles of relapses and remission, leading to inflammation that can cause damage such as fibrosis, which is the excessive build-up of scar tissue in the intestinal wall that can result in narrowing and obstruction. Common symptoms include chronic diarrhea, rectal bleeding, abdominal pain, loss of appetite, and weight loss. Currently, there is no cure for IBD, and treatments aim to induce and maintain remission and prevent flare-ups. Globally, around 4.9 million people suffer from IBD, with the incidence rising in various regions.

The RELIEVE UCCD trial is a 14-week Phase 2b study designed to evaluate the pharmacokinetics, efficacy, safety, and tolerability of duvakitug in adults with UC or CD. Patients in the study are randomly assigned to receive either one of two dose regimens of duvakitug or a placebo. The study is stratified by diagnosis (UC or CD) and previous exposure to advanced IBD treatments. Those who complete the 14-week induction period may enter a long-term extension (LTE) phase, which includes a 44-week maintenance period for responders and a re-induction period for non-responders. The primary endpoints are the number of participants with moderate-to-severe UC who achieve clinical remission and the number of participants with moderate-to-severe CD who have an endoscopic response. The trial is conducted across sites in the U.S., Canada, Europe, and Asia.

Duvakitug (anti-TL1A) is a human IgG1-λ2 monoclonal antibody that targets TL1A, a protein believed to amplify inflammation and drive fibrosis associated with IBD. By targeting TL1A, duvakitug may reduce the overactive immune response in conditions like UC and CD. The safety and efficacy of duvakitug are currently being evaluated in Phase 2b clinical trials and have not yet been reviewed by regulatory authorities.

Teva Pharmaceutical Industries Ltd. is a global leader in pharmaceuticals with expertise in generics and innovative medicines. With over 120 years of history, Teva’s 37,000 employees operate across 58 markets to deliver quality medications and improve patient health outcomes worldwide.