Bristol Myers Squibb (NYSE: BMY) provided an update today following the preliminary analysis of findings from the first of two induction studies within the Phase 3 YELLOWSTONE clinical trial program, which assesses Zeposia (ozanimod) in adult patients dealing with moderate to severe active Crohn’s disease. Unfortunately, the study did not achieve its primary objective of clinical remission by Week 12.
The safety profile of Zeposia in this trial was in line with observations from previous studies. The company intends to conduct a thorough examination of the YELLOWSTONE trial data and collaborate with researchers to disseminate the outcomes to the scientific community at a later time.
Dr. Roland Chen, Senior Vice President and Head of Immunology, Cardiovascular, and Neuroscience Development at Bristol Myers Squibb, remarked, “Thus far, no S1P modulator has demonstrated efficacy in a Phase 3 trial for Crohn’s disease, highlighting the persistent high demand for novel therapies that can provide symptom relief and potential remission to a broader range of patients. While we are disappointed by the lack of success in this initial induction trial, our dedication to advancing groundbreaking scientific research for individuals with immune-mediated conditions remains unwavering. We extend our gratitude to the investigators and patients participating in the YELLOWSTONE clinical trial program.”
The YELLOWSTONE Clinical Trial Program is a Phase 3 initiative spanning multiple centers, encompassing two 12-week induction studies, a 52-week maintenance study, and a 264-week open-label extension study. Its purpose is to assess the safety and efficacy of orally administered Zeposia (ozanimod) in Crohn’s disease patients compared to a placebo. Each induction study involves approximately 600 patients, with responders progressing to the maintenance phase. Nonresponders, individuals experiencing disease relapse during maintenance, and completers of the maintenance study have the opportunity to enroll in the open-label extension trial. Patients in the trial program are administered Zeposia at a dosage of 0.92 mg (equivalent to 1 mg).
The primary endpoint of the induction studies is the proportion of patients achieving a Crohn’s Disease Activity Index (CDAI) score of less than 150. The maintenance study’s co-primary endpoints are the proportion of patients achieving a CDAI score of less than 150 and those experiencing a decrease in Simple Endoscopic Score for Crohn’s disease (SES-CD) score by at least 50% from baseline.
