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

2024-03-29

临床3期并购上市批准临床结果

Bristol Myers Squibb’s Zeposia gained first-in-class nods to treat multiple sclerosis and ulcerative colitis. But the company’s attempt to expand into Crohn’s disease has hit a setback.

Bristol Myers Squibb’s Zeposia (ozanimod) has attracted attention amultiple sclerosisan unulcerative colitisses—multiple sclerosis (MS) and ulcerative Crohn’s disease

Bristol Myers Squibbl fZeposiaspozanimode 1-phosphate (S1P) receptor modulator may be over. Thursday, the New Jemultiple sclerosis (MS)rial ulcerative colitis (UC)ohn’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 WeCrohn’s diseasenot 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,” RoZeposiaen, M.D., BMS’ head of immunology, cardiovascular and neuroscience development, said in a release.

The trial enrS1P modulatorticipants who did not have success with at Crohn’s disease 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 stZeposian 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.

Zeposia S1P receptor modurelapsing MS the competition in October of last year with the FDA approval of Pfizer’s Velsipity, which was gained in the $6.7 billion acJohnson & Johnsona PharmaceutAbbVie Velsipity also is beinEntyviotigated in a pahse 2/3 trial as a treatZeposiar Crohn's disease.