Celgene Announces Results From Phase III SUNBEAM Trial
SUMMIT (dpa-AFX) - Celgene Corp. (CELG) said that its phase III SUNBEAM trial, evaluating the efficacy and safety of ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis or RMS, met the primary endpoint in reducing annualized relapse rate or ARR, compared to weekly interferon (IFN) ?-1a (Avonex).
SUNBEAM evaluated two orally administered treatment doses (0.5 mg and 1 mg) of ozanimod, with patients treated for at least one year. The randomized phase III trial enrolled 1,346 RMS patients in 20 countries.
Top-line data show that both the ozanimod 1 mg and 0.5 mg treatment arms demonstrated statistically significant and clinically meaningful improvements compared to Avonex for the primary endpoint of ARR and the measured secondary endpoints of the number of gadolinium-enhancing MRI lesions and the number of new or enlarging T2 MRI lesions at month 12.
As agreed to in the Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration, a pre-specified analysis on the time to onset of disability progression will be conducted using pooled results from both the SUNBEAM and RADIANCE phase III trials.
The overall safety and tolerability profile was consistent with results from previously reported phase II RMS (RADIANCE) and phase II ulcerative colitis (TOUCHSTONE) trials.
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