Zeposia Reduces Brain Volume Loss and Proves Safe in Long-Term Multiple Sclerosis Study

Bristol Myers Squibb has announced promising new data from its Phase 3 DAYBREAK trial, revealing that patients with relapsing forms of multiple sclerosis (RMS) treated with Zeposia (ozanimod) experienced sustained reductions in brain volume loss over a five-year period. These findings, presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark (September 18-20, 2024), showed that patients on continuous Zeposia therapy had a low and stable rate of whole brain volume (WBV) loss through Month 60, based on data from earlier RADIANCE and SUNBEAM trials.

In the open-label extension (OLE) of the DAYBREAK trial, involving 2,257 patients, the annualized least squares mean (LSM) percentage change in WBV loss was −0.27% for RADIANCE and −0.35% for SUNBEAM from baseline to Month 60. Importantly, patients who switched from interferon beta-1a (IFN-β) to Zeposia showed reductions in brain volume loss, particularly in thalamic and cortical grey matter volumes.

Additionally, a separate safety analysis from the DAYBREAK OLE found that treatment-emergent adverse events (TEAEs) either declined or remained stable over eight years of continuous Zeposia treatment, with relatively low rates of infections, cardiac, hepatic, and pulmonary disorders. This adds to Zeposia’s well-established safety profile, making it an appealing long-term option for patients with RMS.

Dr. Jeffrey Cohen of the Cleveland Clinic emphasized the significance of early treatment in preventing irreversible brain volume loss and cognitive decline in MS patients. "These new analyses reinforce Zeposia’s efficacy, particularly for newly diagnosed patients," Cohen said. Alyssa Johnsen, Senior VP and Head of Clinical Development for Immunology at Bristol Myers Squibb, also stressed the importance of these long-term data in highlighting Zeposia’s role in reducing disease progression over time.

The DAYBREAK trial's long-term data further solidifies Zeposia’s potential in modifying the course of RMS by slowing brain volume loss and improving patient outcomes. Zeposia, an oral sphingosine 1-phosphate (S1P) receptor modulator, works by preventing the migration of lymphocytes into the central nervous system, a process believed to contribute to its therapeutic effects in MS.

Bristol Myers Squibb continues to explore new treatments for neurological disorders, leveraging genetic and biomarker research to develop therapies that can slow disease progression and improve quality of life for patients with multiple sclerosis and other neurodegenerative conditions.