Study met the primary endpoint of annualized relapse rate (ARR) and key secondary MRI endpoints of T2 and GdE lesions, compared to interferon (IFN) β-1a (Avonex®); a very low rate of disability progression observed across the three treatment groups in the pooled analysis; disability endpoint not met
Safety and tolerability consistent with prior phase II and III studies
New Drug Application submission to the U.S. Food and Drug Administration planned by end of 2017
Celgene Corporation (NASDAQ:CELG) today announced that its phase III RADIANCE trial, evaluating the efficacy and safety of ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis (RMS), met the primary endpoint in reducing annualized relapse rate (ARR), compared to weekly interferon (IFN) β-1a (Avonex®).
“The significant effects seen with ozanimod on relapse and MRI outcomes, including brain volume loss, coupled with the safety and tolerability profile observed in the two phase III trials, represent an exciting advancement for a disease which needs additional oral therapies with favorable benefit-risk profiles.”
RADIANCE evaluated two doses (0.5 mg and 1 mg) of oral ozanimod, with patients treated for two years. The trial enrolled 1,313 RMS patients in 21 countries. Both ozanimod 0.5 mg and 1 mg doses demonstrated statistically significant and clinically meaningful reductions in the primary endpoint of ARR and the key secondary endpoints of the number of new or enlarging T2 MRI lesions over 24 months of treatment compared to Avonex and the number of gadolinium-enhancing MRI lesions at 24 months of treatment compared to Avonex®.