Bristol Myers Squibb Presents Data For Multiple Sclerosis Drug Zeposia, Shows Long-Term Efficacy

Wednesday, Bristol Myers Squibb & Co BMY announced new data from the Phase 3 Daybreak trial demonstrating that decreased rates of brain volume loss were sustained in the open-label extension (OLE) for patients treated with Zeposia (ozanimod) for relapsing forms of multiple sclerosis.

These findings showed that patients receiving continuous Zeposia treatment for up to five years experienced low and stable rates of whole brain volume (WBV) loss through Month 60 (annualized least squares mean [LSM] % change from parent trial baseline: Radiance, −0.27; Sunbeam, −0.35).

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Additionally, findings from a separate Daybreak OLE safety analysis demonstrated declining or stable incidence rates of treatment-emergent adverse events (TEAEs), with relatively low rates of infections, serious infections and opportunistic infections over more than eight years of treatment with Zeposia.

These will be presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis.

The Daybreak OLE trial included 2,257 patients from the Sunbeam and Radiance Phase 3 trials and evaluated rates of brain volume loss.

Switching from interferon beta-1a (IFN-β) to Zeposia treatment consistently reduced rates of WBV loss (annualized LSM% change from Radiance baseline to Month 24 and Daybreak baseline to Month 24: −0.48 and −0.19, respectively, with a similar pattern observed in Sunbeam).

Additionally, similar reductions were observed for changes in thalamic volume loss.

High annualized LSM% reductions in cortical grey matter volume (CGMV) were observed with IFN-β (annualized change at Month 12 relative to Sunbeam baseline: −1.02; annualized change at Month 24 relative to RADIANCE baseline: −0.59), but this trend reversed 12 months after switching to Zeposia in Daybreak (annualized LSM% increase relative to Daybreak baseline: patients from Sunbeam, 0.10; patients from Radiance, 0.20), with low annualized LSM% CGMV loss observed after that.

Price Action: BMY stock is up 0.40% at $49.69 during the premarket session at last check Wednesday.

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