Investigational Multiple Sclerosis Drug Reduces Relapses

Celgene recently announced positive results from a phase 3 clinical trial of the investigational multiple sclerosis (MS) drug, ozanimod.

The SUNBEAM trial met its primary endpoint, showing that treatment with ozanimod reduced annual response rate in patients with relapsing multiple sclerosis (RMS), compared with weekly interferon (IFN) β-1a (Avonex) treatment, according to the press release.

"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," said Bruce Cree, PhD, MD, associate professor of Neurology, Multiple Sclerosis Center, Department of Neurology, University of California San Francisco. "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."

The clinical trial evaluated 2 doses, 0.5-mg and 1-mg, of the selective S1P 1 and 5 receptor modulator. Included in the trial were 1346 patients with RMS who were treated for at least 1 year.

The investigators found that both doses of ozanimod resulted in statistically significant and clinically meaningful improvements compared with IFN β-1a, which was the primary endpoint of annualized response rate.

Treatment with ozanimod was also seen to be superior to IFN β-1a for the secondary endpoint of the number of gadolinium-enhancing MRI lesions, and the number of new or enlarging T2 MRI lesions at 1 year, according to the press release.

An analysis on the time to disability progression will be conducted using data from the SUNBEAM and RADIANCE clinical trials, in accordance with the FDA.

Celgene reported that the safety and tolerability profile was consistent with findings from the phase 2 RADIANCE trial and the phase 2 TOUCHSTONE trial, which explored ozanimod in patients with ulcerative colitis.

Ozanimod is in development for immune-inflammatory conditions, such as RMS, ulcerative colitis, and Crohn’s disease.

The drug is believed to inhibit lymphocytes from invading the site of inflammation through binding to S1PR1 receptors, which results in anti-inflammatory effects. Through binding with S1PR5 receptors, the drug is thought to activate cells in the central nervous system. This mechanism has the potential to increase remyelination and prevent synaptic defects, which ultimately prevents neurological damage, according to the press release.

"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, president of Celgene Inflammation and Immunology. "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."