Potential New Therapy for Patients with Relapsing Multiple Sclerosis
Results from the RADIANCE phase 2 trial of ozanimod, an investigational selective S1P 1 and 5 receptor modulators for relapsing multiple sclerosis (MS) patients showed significant reductions in the cumulative number of total gadolinium-enhancing (GdE) lesions.
Results from the RADIANCE phase 2 trial of ozanimod, an investigational selective S1P 1 and 5 receptor modulators for relapsing multiple sclerosis (MS) patients showed significant reductions in the cumulative number of total gadolinium-enhancing (GdE) lesions.
Experts shared their research results at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2016 Forum.
In the 48-week blinded extension part of the study, the patients who were initially randomized to ozanimod continued their assigned dose of 0.5mg, while patients in the placebo group were randomized to either 0.5mg or 1mg dose of ozanimod.
For patents administered ozanimod consistently through week 72, the proportion of patients who were GdE lesion free at week 72 was 73% for the 0.5mg group and 88% for the patients who received a dose of 1mg.
However, both doses saw a higher proportion of patients who were free of GdE lesions at week 24: 84% and 89%, respectively. This reported decrease in unadjusted annualized relapse rate (uARR) between weeks 24 and 72 persisted for all treatment groups, but was more prevalent within the group of patients who received the 1mg dose.
The most commonly reported non-laboratory treatment-emergent adverse events were minor infections: nasopharyngitis, upper respiratory tract, and urinary tract; back pain; and headache.
According to the authors, these data suggest ozanimod has the potential to provide a new oral therapeutic option for patients with relapsing multiple sclerosis who require therapies with “different benefit-risk profiles to help manage their chronic disease.”
Jeffrey Cohen, MD, Director of the Experimental Therapeutics Program, Cleveland Clinic's Mellen Center for Multiple Sclerosis Treatment and Research, commented, “The results of the phase 2 RADIANCE trial and extension support the efficacy and advantageous safety profile of ozanimod. The ongoing phase 3 RADIANCE and SUNBEAM trials are intended to confirm and extend those findings.”
