Bristol Myers Squibb (BMY) has announced positive 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, BMY reported.
At the same time, the safety profile of Zeposia in the True North trial was consistent with previously reported trials.
BMY will now 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… as Zeposia demonstrated consistency across key clinical and endoscopic endpoints,” stated BMY’s chief medical officer, Samit Hirawat, M.D.
Ulcerative colitis, a chronic inflammatory bowel disease (IBD), is characterized by an abnormal, prolonged immune response that creates long-lasting inflammation and ulcers in the mucosa lining of the colon. It is estimated that 12.6 million people worldwide have IBD.
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. Zeposia is already approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults by the FDA and EMA.
Shares in BMY are currently trading down 6% year-to-date. However, analysts have a bullish Strong Buy consensus on the stock with 4 recent buy ratings vs just 1 hold rating. Meanwhile the average analyst price target stands at $66 (9% upside potential). (See BMY stock analysis on TipRanks).
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