Ozanimod Prevents Multiple Sclerosis Relapse in Phase 3 Trial

Multiple sclerosis patients treated with ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, during a phase 3 trial were less likely to relapse than those treated with weekly Avonex (interferon beta-1a, Biogen), according to a press release from Celgene Corporation. 

“The safety and efficacy results from [the RADIANCE phase 3 trial] are consistent with the long-term results from the phase 2 trial (RADIANCE),” Bruce Cree, MD, PhD, associate professor in the department of neurology at the University of California San Francisco, said in the press release. “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.”

In the trial, researchers randomly assigned 1346 relapsing multiple sclerosis (RMS) patients to receive either oral ozanimod at 0.5 mg or 1 mg, or weekly intramuscular Avonex over a minimum of 12 months. To examine the efficacy and safety of the novel treatment, the researchers compared annualized relapse rates between these study groups, as well as changes in hyperintense T2-weighted brain MRI lesions and GdE brain MRI lesions. 

According to the press release, RMS patients treated with ozanimod at both dosages demonstrated significantly reduced relapse incidence compared to those given weekly interferon. The investigational therapy also improved upon interferon in the study’s secondary endpoints, which according to the press release reaffirm safety and efficacy findings collected during previous trials.

“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,” said Scott Smith, MBA, president of Celgene Inflammation and Immunology, said in the release. “We look forward to data from the confirmatory phase 3 RADIANCE trial in the second quarter as we advance toward planned regulatory submissions by year-end.”

Celgene will also be examining the time to onset of disability progression among participants of the SUNBEAM and RADIANCE trials, as per an agreement with the FDA. —Dave Muoio