Bristol Myers Squibb's S1P modulator, Zeposia, failed to meet endpoints in a phase 3 trial of patients with moderate to severe active Crohn’s disease, thwarting the drugmaker's plans to add a new indication to the drug's label.
According to BMS, the phase 3 YELLOWSTONE clinical trial failed to meet its primary endpoint of clinical remission at week 12. In the two 12-week induction studies, which included approximately 600 patients each, oral Zeposia was compared to placebo in patients with Crohn’s disease.
Zeposia is an oral, sphingosine 1-phosphate receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia blocks the capacity of lymphocytes to leave lymph nodes, reducing the number of lymphocytes in peripheral blood. BMS was hopeful that Zeposia, by reducing lymphocyte migration into the gut, would prove effective in Crohn’s disease.
BMS picked up the drug in its $74 billion acquisition of Celgene in 2019. The drug snagged its first FDA approval in March 2020 for adults with relapsing forms of multiple sclerosis. In May 2021, Zeposia was approved for the treatment of adults with moderately to severely active ulcerative colitis, introducing a new option that has a different mechanism of action than available therapies.
The treatment was touted as a potential blockbuster, but so far, hasn't hit the market yet, bringing in $434 million in 2023.
