French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) and Israel-based pharmaceutical company Teva Pharmaceutical Industries Ltd (NYSE:TEVA) (TASE:TEVA), on Tuesday reported positive long-term extension results from the RELIEVE UCCD phase 2b study of duvakitug, an investigational TL1A-targeting monoclonal antibody, demonstrating sustained clinical and endoscopic efficacy over 44 weeks in ulcerative colitis and Crohn's disease patients who responded to induction therapy.

The double-blind randomised study evaluated long-term efficacy, safety, and tolerability, reinforcing earlier induction findings that showed clinically meaningful response at week 14 versus placebo.

Among 130 responders re-randomised to 450 mg or 900 mg subcutaneous dosing every four weeks for up to 58 weeks of exposure, week-44 outcomes showed clinical remission in ulcerative colitis of 58% (900 mg) and 47% (450 mg), and endoscopic response in Crohn's disease of 55% (900 mg) and 41% (450 mg), with consistent benefits across additional endpoints. Both doses were well tolerated, with adverse events including upper respiratory tract infection, nasopharyngitis, Crohn's disease, and hypertension consistent with induction-phase safety.

Sanofi and Teva are co-developing and co-commercialising duvakitug globally, sharing development costs and major-market economics, with Sanofi leading phase 3 development. Teva will lead commercialisation of the product in Europe, Israel, and certain other markets, and Sanofi will lead commercialisation in North America, Japan, other parts of Asia, and the rest of the world.