Long-term treatment for up to 12o weeks, with the investigational drug Ozanimod (RPC-1063), found to be effective and safe in patients with relapsing multiple sclerosis (RMS) who participated in the RADIANCE clinical trial.
Celgene, Ozanimod’s developer, presented the study, “Efficacy and Safety of Ozanimod in the Blinded Extension (120 Weeks) of RADIANCE, a Phase 2 Trial in Relapsing Multiple Sclerosis,” at the 2017 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), held May 24-27 in New Orleans.
Ozanimod is an oral, selective sphingosine 1-phosphate (S1PR1) and 5 (S1PR5) receptor modulator for RMS treatment. By binding to S1PR1 and S1PR5 receptors, ozanimod inhibits the mobilization of certain immune cells towards inflammation sites. That reduces the number of circulating immune cells.
In the study, researchers proposed further evaluating the safety and efficacy of ozanimod at 120 weeks. They analyzed results from patients in the RADIANCE Part A Phase 2 trial (NCT01628393), in which RMS patients were randomly given a once-daily dose of 0.5 mg or 1.0 mg of ozanimod, or placebo for 24 weeks.
At week 24, patients had the option to enter a 96-week extension phase. Patients in the placebo group were re-randomized to ozanimod 0.5 mg or 1.0 mg groups; 89 percent of the 0.5 mg dose group and 90 percent of the 1.0 mg dose group completed the 120-week treatment period.
The team observed that at week 120, the unadjusted annualized relapse rates were 0.31 percent for the 0.5 mg group and 0.18 percent for the 1.0 mg group.
In addition, 79 percent of the 0.5 mg group and 76 percent of the 1.0 mg group experienced at least one treatment-emergent adverse effect. The most common of these were an increase in levels of alanine aminotransferases (enzymes found in the liver), naso-pharyngitis (inflammation of the nose and pharynx), and upper respiratory tract infection.
Researchers reported “no notable cases of pulmonary treatment-emergent adverse effects and no cases of macular edema, malignancy-related treatment-emergent adverse effects, or serious opportunistic infections.”
The team concluded: “Both ozanimod doses demonstrated durable efficacy, with a favorable safety profile in patients continuing ozanimod for 120 weeks or switching from placebo to ozanimod for 96 weeks. These data support the ongoing RADIANCE and SUNBEAM Phase 3 studies.”
Celgene, based in Summit, New Jersey, recently reported results from the Phase 3 RADIANCE trial (NCT02047734) and Phase 3 SUNBEAM trial (NCT02294058) showing that RMS patients receiving Ozanimod had lower relapse rates and fewer brain MRI lesions than those on weekly Avonex (interferon β-1a) therapy.