Teva, Sanofi report RELIEVE UCCD Phase 2b study met primary endpoints

Sanofi (SNY) and Teva Pharmaceuticals (TEVA) announced that the RELIEVE UCCD phase 2b study met its primary endpoints in patients with ulcerative colitis and Crohn’s disease. RELIEVE UCCD assessed duvakitug, a human IgG1-2 monoclonal antibody targeting TL1A, for the treatment of moderate-to-severe inflammatory bowel disease. In the RELIEVE UCCD study, 36.2% and 47.8% of patients with UC treated with duvakitug achieved clinical remission compared to 20.45% on placebo, placebo-adjusted rates were 15.7% and 27.4%, at week 14. In patients with CD, 26.1% and 47.8% treated with duvakitug achieved endoscopic response compared to 13.0% on placebo, placebo-adjusted rates were 13.0% and 34.8%, at week 14. Overall, the treatment effect was consistent across subgroups. This is the first and only randomized, placebo-controlled study to evaluate the impact of an anti-TL1A monoclonal antibody in CD. Detailed results are expected to be presented at a scientific forum in 2025. Duvakitug was generally well tolerated in both UC and CD with no safety signal identified. Overall rates of treatment emergent adverse events were similar between duvakitug and placebo across both UC and CD. All AEs reported across both UC and CD were less than 5%. Duvakitug is currently under clinical investigation, and its efficacy and safety have not been evaluated by any regulatory authority.