Bristol Myers Squibb’s Zeposia Misses Mark in Phase 3 Crohn’s Disease Study

1. Bristol Myers Squibb's Zeposia, an orally administered sphingosine 1-phosphate (S1P) receptor modulator, has not met its primary endpoint of clinical remission at Week 12 in the first induction study of the Phase 3 YELLOWSTONE program for treating Crohn's disease.
2. The trial enrolled approximately 600 participants who had previously experienced unsuccessful treatments.
3. Despite the setback, no S1P modulators have shown efficacy in a Phase 3 trial for Crohn's disease, highlighting the high unmet medical need for new therapies offering symptom relief and potential remissions.
4. Zeposia was approved for relapsing multiple sclerosis (MS) in 2020 and ulcerative colitis (UC) in 2021, providing patients with alternatives to biologic treatments like Stelara, Humira, and Entyvio.
5. The YELLOWSTONE program includes two 12-week induction studies, a 52-week maintenance study, and a 264-week open-label extension study.
6. Another S1P receptor modulator, Pfizer's Velsipity, is also being investigated in a Phase 2/3 trial as a treatment for Crohn's disease.
7. Zeposia generated $434 million in sales last year, with BMS estimating it will reach $3 billion by 2030.