Bristol Myers Squibb announced an update following the initial analysis of results from the first of two induction studies in the Phase 3 YELLOWSTONE clinical trial program evaluating Zeposia (ozanimod) in adult patients with moderate to severe active Crohn’s disease. The study did not meet its primary endpoint of clinical remission at Week 12.
The safety profile of Zeposia in this study was consistent with that observed in previously reported trials. The company will complete a full evaluation of the YELLOWSTONE trial data and work with investigators to share the results with the scientific community in the future.
“To date, no S1P modulator has shown an effect in a Phase 3 trial in Crohn’s disease, where a high unmet medical need remains for new therapies that offer more patients relief from symptoms and the potential for remission,” said Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb. “While we are disappointed that the primary endpoint was not reached in this first induction trial, we are committed to driving transformative science on behalf of individuals with immune-mediated diseases and would like to thank the investigators and patients who are participating in the YELLOWSTONE clinical trial program.”
About the YELLOWSTONE Clinical Trial Program
YELLOWSTONE is a Phase 3, multicenter clinical trial program consisting of two 12-week induction studies, a 52-week maintenance study and a 264-week open-label extension study. YELLOWSTONE is designed to evaluate the safety and efficacy of Zeposia (ozanimod) administered orally to patients with Crohn’s disease versus placebo. The induction studies include approximately 600 patients each, with responders moving on to participate in the maintenance study. Nonresponders, those with disease relapse during maintenance, and completers of the maintenance study have the option to enroll in the open-label extension trial. Patients in the trial program are receiving Zeposia 0.92 mg (equivalent to 1 mg).
The primary endpoint of the induction studies is the proportion of patients with a Crohn’s Disease Activity Index (CDAI) score of less than 150. The co-primary endpoints of the maintenance study are the proportion of patients with a CDAI score of less than 150 and the proportion of patients with a Simple Endoscopic Score for Crohn’s disease (SES-CD) score decrease from baseline of at least 50%.
About Crohn’s disease
Crohn's disease is a chronic inflammatory bowel disease (IBD) affecting the digestive tract. IBD results in the swelling or inflammation of the intestines, which may result in permanent damage and impact everyday life during disease flares. It is estimated that approximately 12.6 million people worldwide have IBD.
For many patients, Crohn’s disease occurs in the colon or the third segment of the small intestine, the ileum, but may occur in any part of the intestinal tract. Signs and symptoms of Crohn’s disease can range from mild to severe. Most often, symptoms appear gradually but can sometimes develop suddenly or without warning. Patients with Crohn’s disease may experience ongoing disease symptoms, or have episodes of symptom-free remission, which can be followed by relapse or flares. Patients with Crohn's disease are also at an increased risk of developing colorectal cancer. Living with Crohn’s disease may severely affect quality of life both physically and psychologically, particularly during disease flares and relapses.
Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients’ Lives
Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can take a toll on their physical, emotional and social well-being, making simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, and our passion to help patients, the company continues to pursue pathbreaking science with the goal of delivering meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and pulmonology. We follow the science, aiming to tailor therapies to individual needs, improve outcomes and expand treatment options by working to identify mechanisms with the potential to achieve long-term remission – and perhaps even cures – in the future. By building partnerships with researchers, patients and caregivers to deliver innovative treatments, Bristol Myers Squibb strives to elevate patient care to new standards and deliver what matters most – the promise of living a better life.
About Zeposia (ozanimod)
Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which Zeposia exerts therapeutic effects in Crohn’s disease is unknown but may involve the reduction of lymphocyte migration into the gut.Zeposia is approved in numerous countries around the world for the treatment of adults with relapsing forms of MS and adults with moderately to severely active ulcerative colitis.
