A Phase 3 clinical trial evaluating the safety and effectiveness of ozanimod (RPC-1063) in patients with relapsing multiple sclerosis (RMS) shows treatment reduced the disease’s annualized relapse rate (ARR), researchers reported.
The Phase 3 SUNBEAM trial (NCT02294058) tested ozanimod, an oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator designed to treat immune-inflammatory conditions such as RMS. Lowering ARR was this study’s primary goal for the treatment, being developed by Celgene Corporation.
Those with RMS can experience relapses — also called flare-ups or exacerbations — that worsen their neurologic function. Relapses are usually followed by partial or complete recovery periods, called remissions, during which symptoms cease or partially improve, and the disease appears to stabilize.
Ozanimod works by binding to S1PR1 and S1PR5 receptors. The binding inhibits certain lymphocytes, or immune cells, from migrating to sites of inflammation. This reduces circulating T- and B-lymphocytes, stabilizing immune function.
The SUNBEAM study enrolled 1,346 RMS patients at 152 sites in 20 countries. Researchers compared the safety, effectiveness and tolerability of two oral doses of ozanimod — 0.5 mg and 1 mg — with an intramuscular injection of interferon beta-1a (Avonex) once a week for at least 12 months.
Both doses of ozanimod were much more effective (showed statistically significant and clinically meaningful improvement) compared to Avonex in achieving the trial’s primary objective — a lower relapse rate — and the secondary endpoint of fewer brain MRI lesions over 12 months, data showed.
Ozanimod’s overall safety and tolerability profile was consistent with that reported in previous studies, such as the Phase 2-3 RADIANCE (NCT02047734) trial in MS patients, and a Phase 2 study in people with ulcerative colitis, the company also reported.
“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,” Bruce Cree, associate professor of neurology at the University of California, San Francisco, said in a press release. “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.”
A long-term and open-label (meaning no placebo group) extension study (NCT02576717) involving some 2,350 RMS patients from previous trials is now underway. This safety and efficacy study is expected to include in June 2020.
Researchers will also, under an agreement with the U.S. Food and Drug Administration (FDA), analyze the time it takes for patients’ condition to progress to disability. Their measuring stick will be a deterioration of 1 or more points in a patient’s Expanded Disability Status Scale (EDSS) score, confirmed after three and six months. This analysis will use data from both the Phase 3 SUNBEAM and RADIANCE 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, 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.”
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