Bristol Myers Squibb's versatile Zeposia doesn't make the grade in Crohn's disease trial

Bristol Myers Squibb’s Zeposia (ozanimod) has attracted attention as a treatment for an unusual duo of diseases—multiple sclerosis (MS) and ulcerative colitis (UC).

But the approval roll for the sphingosine 1-phosphate (S1P) receptor modulator may be over. Thursday, the New Jersey company said its trial assessing Zeposia in Crohn’s disease had come up short.

The company said an initial analysis of results from a 12-week induction study showed that the drug did not meet its primary endpoint of clinical remission at Week 12. BMS did not provide detailed data nor reveal its plan for Zeposia in the indication.

“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,” Roland Chen, M.D., BMS’ head of immunology, cardiovascular and neuroscience development, said in a release.

The trial enrolled 600 participants who did not have success with at least one prior treatment and is the first of two 12-week induction studies comparing Zeposia to placebo.

Also part of the YELLOWSTONE program is a 52-week maintenance study for those who responded to treatment and an optional, 264-week, open-label extension study open to non-responders, plus those with disease relapse during maintenance and those who completed the maintenance trial.

Zeposia was approved for relapsing MS in 2020. A year later came the UC nod, providing patients with a first-in-class alternatives to biologic treatments such as Johnson & Johnson’s Stelara, AbbVie’s Humira and Takeda’s Entyvio, which have dominated the indication. Zeposia is administered orally as opposed to the biologics, which are infused.

Another S1P receptor modulator joined the competition in October of last year with the FDA approval of Pfizer’s Velsipity, which was gained in the $6.7 billion acquisition of Arena Pharmaceuticals. Velsipity also is being investigated in a pahse 2/3 trial as a treatment for Crohn's disease.

Zeposia generated $434 million in sales last year, which was up 74% from 2022. BMS has estimated Zeposia will reach sales of $3 billion by 2030.