Inflammatory bowel disease drug meets primary endpoints in late-stage study
Patients with ulcerative colitis treated with ozanimod (Zeposia, Bristol-Myers Squibb) experienced significant clinical remission when compared with those taking a placebo, according to data from a Phase 3 trial evaluating ozanimod as an induction and maintenance therapy in patients with moderate to severe ulcerative colitis.
The primary endpoints of demonstrating highly statistically significant results for induction of clinical remission at week 10 and in maintenance at week 52, and the secondary endpoints of clinical response and endoscopic improvement in induction at week 10 and in maintenance at week 52, were met.
“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, MD, chief medical officer, Bristol Myers Squibb, in a press release. “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.”
Read more about the study here.