Bristol Myers Squibb declares positive results of Zeposia from phase 3 DAYBREAK open-label extension trial in patients with MS (relapsing forms)

Bristol Myers Squibb revealed findings from the phase 3 DAYBREAK trial, demonstrating Zeposia's (ozanimod) enduring efficacy and safety in relapsing forms of multiple sclerosis (MS). These results, along with nine other abstracts, will be presented at the 9th annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024. In the long-term extension study, Zeposia showed a low annualized relapse rate of 0.098, with 82.8% and 84.8% of participants showing no confirmed disability progression at three and six months, respectively. Safety data over an average 60.9-month period indicated that 89.0% of participants experienced any treatment-emergent adverse events (TEAEs). Notably, no new safety concerns emerged. Additionally, a separate analysis evaluated rebound risk post-Zeposia discontinuation. Zeposia, an oral sphingosine 1-phosphate (S1P) receptor modulator, is approved for MS (relapsing forms) and moderately to severely active ulcerative colitis.