Sanofi, Teva report positive Phase 2b results for ulcerative colitis and Crohn's disease drug

Sanofi and Teva Pharmaceuticals announced that their drug candidate duvakitug met its primary endpoints in the RELIEVE UCCD Phase 2b study for patients with moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD).

The study found that 47.8% of UC patients receiving a high dose of duvakitug achieved clinical remission at week 14, compared to 20.45% on placebo. For Crohn's disease patients, 47.8% on a high dose of duvakitug achieved endoscopic response at week 14, versus 13.0% on placebo. The primary endpoint results for the high dose represent the highest rates achieved with any TL1A monoclonal antibody.

Duvakitug was generally well tolerated in both UC and CD patients, with no safety signals identified. The overall rates of treatment-emergent adverse events were similar between the duvakitug and placebo groups. Based on these results, Sanofi and Teva plan to initiate Phase 3 development for IBD, pending regulatory discussions.

This is the first and only randomized, placebo-controlled study to evaluate an anti-TL1A monoclonal antibody in Crohn's disease. Detailed results are expected to be presented at a scientific forum in 2025. Duvakitug's efficacy and safety have not yet been evaluated by any regulatory authority.