PRINCETON, N.J. - Bristol Myers Squibb (NYSE: NYSE:BMY) reported today that its Phase 3 YELLOWSTONE clinical trial for Zeposia (ozanimod) did not meet its primary endpoint of clinical remission at Week 12 for treating moderate to severe active Crohn's disease in adults. Despite the setback, the safety profile of Zeposia was consistent with previous trials.
The YELLOWSTONE program, a multicenter trial, includes two 12-week induction studies, a 52-week maintenance study, and a 264-week open-label extension study. The program aimed to assess the safety and efficacy of orally administered Zeposia versus placebo. Around 600 patients participated in each induction study, with responders advancing to the maintenance study and nonresponders having the option to join the open-label extension trial.
Crohn's disease is a chronic inflammatory bowel disease affecting millions globally. It can severely impact quality of life, and there is a significant need for new therapies that can offer symptom relief and potential remission.
Dr. Roland Chen, MD, senior vice president and head of Immunology, Cardiovascular, and Neuroscience development at Bristol Myers Squibb, expressed disappointment in not meeting the primary endpoint but reaffirmed the company's commitment to advancing science for immune-mediated diseases. He thanked the investigators and patients involved in the YELLOWSTONE program.
Zeposia, an S1P receptor modulator, is already approved in many countries for relapsing forms of multiple sclerosis (MS) and moderately to severely active ulcerative colitis (UC). The exact mechanism by which Zeposia operates in Crohn's disease remains unknown, but it may involve reducing lymphocyte migration into the gut.
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