Teva and Sanofi Present New Positive Phase 2b Study Results at ECCO 2025 Reinforcing Best-in-Class Potential of Duvakitug (Anti-TL1A) in Ulcerative Colitis and Crohn's Disease

Core Insights - Teva Pharmaceuticals and Sanofi presented new results from the RELIEVE UCCD Phase 2b study of duvakitug, a monoclonal antibody for treating moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD) at the ECCO Congress in Berlin [1] Ulcerative Colitis (UC) Findings - In the UC cohort, 36% of patients on the 450 mg dose and 48% on the 900 mg dose achieved clinical remission at week 14, compared to 20% on placebo, with placebo-adjusted rates of 16% and 27% respectively [2] - Higher clinical remission rates were noted in both advanced therapy-experienced and naïve subgroups [2] Crohn's Disease (CD) Findings - In the CD cohort, 26% of patients on the 450 mg dose and 48% on the 900 mg dose achieved endoscopic response at week 14, compared to 13% on placebo, with placebo-adjusted rates of 13% and 35% respectively [4] - Similar to UC, higher endoscopic response rates were observed in both advanced therapy-experienced and naïve subgroups [4] Additional Efficacy Data - The study showed overall efficacy and safety of duvakitug across all pre-specified subgroups, with new endpoints including clinical and endoscopic outcomes and histological-endoscopic mucosal improvement [5] - The findings will support a Phase 3 program anticipated to start in H2 2025 [5] Safety Profile - Duvakitug was generally well tolerated in both UC and CD cohorts, with no emergent safety signals or dose-dependent adverse events observed [9] Collaboration Details - Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug, sharing development costs and profits in major markets, with Sanofi leading the Phase 3 clinical development program [17]