Zeposia Misses Main Goal in Crohn's Phase III Study

Bristol Myers Squibb has reported that its medication Zeposia (ozanimod) did not achieve its main goal in a Phase III trial for patients with active Crohn’s disease of moderate to severe intensity. The company did not disclose detailed results but stated that the drug did not lead to clinical remission after a 12-week period. The safety profile of the drug remained in line with earlier studies.

Roland Chen, who oversees immunology, cardiovascular, and neuroscience development at Bristol Myers Squibb, expressed disappointment over the results. He noted that no S1P modulator has been successful in a Phase III trial for Crohn’s disease, where there is a significant need for new treatments that can alleviate symptoms and potentially offer remission.

Zeposia is an oral medication that targets specific S1P receptors and is thought to function by hindering lymphocytes from exiting lymph nodes and entering the intestines. It was initially approved by the FDA in 2020 for treating multiple sclerosis and later for ulcerative colitis.

The Phase III YELLOWSTONE program, which included two 12-week trials with approximately 600 participants each, was designed to test the drug's efficacy in treating Crohn’s disease. Those who responded to the initial treatment proceeded to a 52-week maintenance phase and then to an open-label extension phase lasting 264 weeks. The primary outcome measure for the trial was a clinical remission score.

Bristol Myers Squibb is currently analyzing the full data from the YELLOWSTONE program and plans to collaborate with the trial investigators to disseminate the findings to the scientific community.

This setback comes after a series of positive outcomes for the pharmaceutical company. Recently, they reported that a combination of Opdivo and Yervoy significantly improved survival rates in patients with advanced liver cancer. Additionally, an Opdivo-based regimen was approved as a first-line treatment for inoperable or metastatic bladder cancer.