Feb 17, 2017
Celgene Corporation has announced that its phase III SUNBEAM trial that evaluates the safety and efficacy 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) ?-1a (Avonex®).
Top-line data show that both the ozanimod 0.5 mg and 1 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. The overall tolerability and safety profile was consistent with results from previously reported phase II RMS (RADIANCE) and phase II ulcerative colitis (TOUCHSTONE) trials.
Bruce Cree, Associate Professor of Neurology, Multiple Sclerosis Center, Department of Neurology, University of California San Francisco, said: “The safety and efficacy results from SUNBEAM are consistent with the long-term results from the phase II trial (RADIANCE). These data add to the growing body of evidence supporting the use of ozanimod as a disease modifying therapy for relapsing forms of multiple sclerosis. We look forward to the continued study of ozanimod as well as presentation of the full results of the phase III trial at an upcoming international scientific meeting.”
“People living with multiple sclerosis need additional therapies and we are pleased that oral ozanimod showed meaningful improvements across primary and measured secondary endpoints in this study. We look forward to data from the confirmatory phase III RADIANCE trial in the second quarter as we advance toward planned regulatory submissions by year-end,” said Scott Smith, President of Celgene Inflammation and Immunology.Celgene Announces Positive Results from Phase III SUNBEAM Trial of Oral Ozanimod in Patients with Relapsing Multiple Sclerosislast edit: 2017-02-28T16:59:36+00:00da