Phase 3 Trial Reports Ozanimod Cuts Multiple Sclerosis Relapse Rate

Results from the Phase 3 SUNBEAM trial reported that using ozanimod (RPC-1063/Celgene) to treat patients with relapsing multiple sclerosis (RMS) significantly reduced MS annualized relapse rate (ARR).

Researchers from the University of California San Francisco led by Bruce Cree, MD, PhD, Department of Neurology aimed to assess the safety and efficacy of ozanimod, an oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator designed to treat immune-inflammatory conditions like RMS — the trial’s primary goal was to lower ARR.

The SUNBEAM study enrolled 1,346 patients at 152 sites in 20 countries. The team also compared tolerability of two oral doses of ozanimod, 0.5mg and 1mg, with an intramuscular injection of interferon beta-1a (Avonex/Biogen) once a week for at least a 12-month period.

According to study results, compared to Avonex, both doses of ozanimod were more effective in reducing relapse rates. The team also highlighted that ozanimod’s overall safety and tolerability profile had been consistent with previous studies — phase 2 and 3 RADIANCE trials and a phase 2 ulcerative colitis (TOUCHSTONE) trial.

RMS patients often suffer relapses that can exacerbate their neurologic function. The researchers believed ozanimod could work by binding to S1PR1 and S1PR5 receptors, inhibiting certain lymphocytes from transferring to inflammation sites thereby stabilizing immune function.

“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 Cree.

Under the Special Protocol Assessment (SPA) agreement with the US Food and Drug Administration (FDA), the research team will use data from the RADIANCE and TOUCHSTONE trials to assess the time it takes for patients’ condition to progress to disability.

The paper, "Safety and efficiacy of the selective sphingosine 1-phosphate receptor modulator ozanimod in relapsing multiple sclerosis (RADIANCE): a randomised, placebo-controlled, phase 2 trial," was published in The Lancet.