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Bristol Myers : Phase 3 True North Trial On Ulcerative Colitis Meets Primary Endpoints

Bristol Myers Squibb (BMY) reported that a Pivotal Phase 3 True North Trial met primary endpoints, demonstrating highly statistically significant 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 trial evaluated oral Zeposia (ozanimod) as an induction and maintenance therapy for adult patients with moderate to severe ulcerative colitis.

The safety profile of Zeposia in the True North trial was consistent with that observed in previously reported trials.

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.

Ulcerative colitis, a chronic inflammatory bowel disease (IBD), is characterized by an abnormal, prolonged immune response that creates long-lasting inflammation and ulcers (sores) in the mucosa (lining) of the large intestine (colon). Symptoms, including bloody stools, severe diarrhea and frequent abdominal pain, usually develop over time rather than suddenly.

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