Bristol Myers Squibb announced results from True North, a pivotal Phase 3 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.
“Patients with ulcerative colitis can struggle to effectively manage this often unpredictable and potentially debilitating disease. The True North results are encouraging for patients living with moderate to severe ulcerative colitis as Zeposia demonstrated consistency across key clinical and endoscopic endpoints, suggesting Zeposia may address the need for new oral therapy options with a favorable benefit to risk profile in the treatment journey,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “At Bristol Myers Squibb, we are committed to researching innovative treatment options that may elevate the standard of care for people living with ulcerative colitis, with a focus on finding solutions that have the potential to transform outcomes for the inflammatory bowel disease community.”
Bristol Myers Squibb is also investigating Zeposia for the treatment of moderately to severely active Crohn’s disease in the ongoing Phase 3 YELLOWSTONE clinical trial program.
Source: Company Press Release