Zeposia met primary and secondary endpoints in TRUE NORTH Phase III study for adult patients with moderate to severe ulcerative colitis.- BMS

Bristol Myers Squibb announced results from True North, a pivotal Phase III trial evaluating oral Zeposia (ozanimod) as an induction and maintenance therapy for adult patients with moderate to severe ulcerative colitis .

True North met both primary endpoints, demonstrating highly statistically significant (p-value < 0.0001) results for induction of clinical remission at Week 10 and in maintenance at Week 52. The study also met key secondary endpoints of clinical response and endoscopic improvement in induction at Week 10 and in maintenance at Week 52. The safety profile of Zeposia in the True North trial was consistent with that observed in previously reported trials. The company will complete a full evaluation of the True North data and work with investigators to present detailed results at a future medical meeting, as well as discuss these results with health authorities.

Bristol Myers Squibb is also investigating Zeposia for the treatment of moderately to severely active Crohn’s disease in the ongoing Phase III YELLOWSTONE clinical trial program.