Zeposia medication from Bristol Myers Squibb falls short in a study for Crohn’s disease

As a therapy for two uncommon illnesses, ulcerative colitis (UC) and multiple sclerosis (MS), Bristol Myers Squibb’s Zeposia (ozanimod) has garnered interest. However, the sphingosine 1-phosphate (S1P) receptor modulator’s approval era may be coming to an end. The New Jersey-based business reported that its trial evaluating Zeposia in Crohn’s disease had not shown positive results.
The medication did not achieve its primary aim of clinical remission at Week 12, according to the company’s preliminary analysis of data from a 12-week induction trial. In the indication, BMS did not disclose its strategy for Zeposia or offer specific statistics.
Roland Chen, head of BMS’s immunology, cardiovascular, and neuroscience development, stated in a release that “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.”

The experiment, the first of two 12-week induction trials comparing Zeposia against placebo, recruited 600 people who had not responded to at least one previous medication.
A 52-week maintenance study for patients who responded to therapy and a 264-week, open-label extension study that is voluntary and available to non-responders, patients who experienced a disease recurrence during maintenance, and maintenance trial participants are also included in the YELLOWSTONE program.
In 2020, Zeposia was approved for treating relapse MS. When the UC nod was granted a year later, patients had access to first-in-class substitutes for biologic medicines like Takeda’s Entyvio, Johnson & Johnson’s Stelara, and AbbVie’s Humira, which have dominated the indication. In contrast to biologics, which are infused, zeposia is delivered orally.
The FDA approved Velsipity, an S1P receptor modulator made possible by Pfizer’s $6.7 billion acquisition of Arena Pharmaceuticals, in October of last year, adding another player to the competition. Another phase 2/3 experiment is looking into velsipity as a possible Crohn’s disease therapy.

Zeposia’s revenue in 2023 was $434 million, a 74% increase over 2022 revenues. According to BMS estimates, Zeposia’s revenues are expected to reach $3 billion by 2030.