Novel Oral MS Drug Effective, Safe in Phase 3 Study
SUNBEAM is a randomized, multicenter, double-blind, double-dummy, active-controlled Phase 3 study evaluating the efficacy, safety and tolerability of oral ozanimod (0.5mg and 1mg) compared to intramuscular IFN β-1a (Avonex) in 1,346 RMS patients over a minimum of 12 months.
The primary endpoint was the reduction of annualized relapse rate (ARR) during the treatment period. Secondary endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 12 months and the number of GdE brain MRI lesions at month 12.
Study data showed that both ozanimod 0.5mg and 1mg doses demonstrated statistically significant and clinically meaningful improvements in ARR, as well as the number of gadolinium-enhancing MRI lesions and the number of new or enlarging T2 MRI lesions at month 12, compared to IFN β-1a. Additionally, the SUNBEAM study found ozanimod to have an overall safety and tolerability profile consistent with those from previous Phase 2 studies.
Ozanimod, a novel, selective, sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator, is currently under investigation for immune-inflammatory conditions such as RMS, ulcerative colitis and Crohn's disease.
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