Teva and Sanofi Report Positive Phase 2b Results for Duvakitug in Ulcerative Colitis and Crohn’s Disease

Teva Pharmaceuticals and Sanofi have announced promising results from their Phase 2b RELIEVE UCCD study involving patients with ulcerative colitis (UC) and Crohn’s disease (CD). These conditions are the most prevalent forms of inflammatory bowel disease (IBD), which cause debilitating symptoms like abdominal pain and diarrhea due to chronic inflammation of the gastrointestinal tract. The study focused on evaluating duvakitug (TEV’574/SAR447189), a human monoclonal antibody targeting TL1A, for patients with moderate-to-severe IBD.

In the RELIEVE UCCD study, duvakitug demonstrated significant efficacy in achieving clinical remission in UC and an endoscopic response in CD. For UC, 36.2% of patients on a low dose and 47.8% on a high dose of duvakitug reached clinical remission, compared to 20.45% on placebo. The placebo-adjusted remission rates were 15.7% for the low dose and 27.4% for the high dose. In CD patients, 26.1% on a low dose and 47.8% on a high dose of duvakitug attained an endoscopic response, in contrast to 13.0% on placebo, with placebo-adjusted rates standing at 13.0% and 34.8%, respectively. These results were achieved at the 14-week mark, demonstrating the promising potential of duvakitug in treating IBD. Moreover, this study is the first randomized, placebo-controlled trial evaluating the impact of an anti-TL1A monoclonal antibody in CD.

The study also reported that duvakitug was generally well-tolerated among participants, with no significant safety concerns. The occurrence of treatment emergent adverse events (AEs) was comparable between the duvakitug and placebo groups, each at 50%, with all reported AEs being below 5%.

Eric Hughes, MD, PhD, the Head of Global R&D and Chief Medical Officer at Teva, expressed optimism about the study's outcomes. He highlighted the potential of duvakitug to significantly enhance the quality of life for individuals suffering from IBD. The collaboration with Sanofi is set to continue into the next phase of development, aiming to make this treatment available to more patients in need.

Duvakitug is under clinical investigation and has not yet received regulatory evaluation for efficacy and safety. The positive results from the study have led Teva and Sanofi to plan the initiation of Phase 3 trials, pending regulatory discussions. These trials will further assess the drug's impact on IBD, aiming to confirm the promising results seen in the Phase 2b study.

Sanofi's Executive Vice President, Houman Ashrafian, MD, PhD, remarked on the groundbreaking nature of the study results, indicating that duvakitug could become a pivotal treatment option for UC and CD, offering much-needed alternatives for patients. He emphasized Sanofi’s commitment to rapidly advancing innovative medicines by following scientific insights.

Teva and Sanofi are working in partnership to develop and commercialize duvakitug. They will share development costs globally, split profits and losses in key markets, and adhere to a royalty arrangement in other regions. Sanofi will spearhead the Phase 3 clinical trials, while Teva will manage the commercialization in Europe, Israel, and selected countries, with Sanofi handling North America, Japan, and other parts of Asia.

Overall, the RELIEVE UCCD study represents a significant step forward in the potential treatment of IBD, with duvakitug showing considerable promise in improving outcomes for patients with moderate to severe UC and CD. Further research in the upcoming Phase 3 trials will be crucial to validate these findings and bring this potential treatment closer to market availability.