#AAN2018 – Celgene to Present Latest Data on Ozanimod’s Safety and Effectiveness

Celgene’s oral treatment candidate ozanimod can effectively reduce relapse rates in multiple sclerosis (MS) patients with mild to moderate disability, results of two Phase 3 trials show.

The company will present data on the SUNBEAM (NCT02294058) and RADIANCE (NCT02047734) trials in two presentations at the 2018 Annual Meeting of the American Academy of Neurology (AAN), underway in Los Angeles through April 27.

Both studies evaluated the efficacy and safety of 1 mg or 0.5 mg capsules of ozanimod compared to intramuscular injections of 30 μg of Biogen’s Avonex (interferon beta-1a) in a total of 2,659 people with relapsing MS.

During the SUNBEAM trial, patients treated daily with both ozanimod doses experienced fewer relapses per year compared to those treated with Avonex — 0.195 with ozanimod at 1 mg, 0.210 with ozanimod at 0.5 mg, and 0.338 for those given Avonex as a weekly injection, the data show.

This beneficial effect was found both in patients new disease-modifying therapies, as well as in those who had already used such therapies.

Similar results were also reported in the RADIANCE trial, which evaluated the treatment’s effectiveness over 24 months. Both ozanimod doses were seen to be more effective in reducing annualized relapse rates (ARR) than Avonex — 0.157 and 0.228 with ozanimod 1 and 0.5 mg, respectively, and 0.246 with Avonex.

Researchers also evaluated ARR according to each patient’s disability status. Those with mild disability (EDSS of less than 3.5) had lower ARR when treated with the investigative drug — 0.170 and 0.214 with ozanimod 1 and 0.5 mg, respectively, compared to 0.369 with Avonex.

Similarly, patients with moderate disability (EDSS higher than 3.5) also showed ARR benefits with the treatment — 0.145 and 0.210 with ozanimod at 1 and 0.5 mg, respectively, and 0.215 if given Avonex.

These efficacy findings and additional subgroup analyses will be presented in the study “Efficacy of Ozanimod Versus Interferon β-1a by Prior Treatment and Baseline Disability in Two Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled, Double-Dummy Phase 3 Studies in Relapsing Multiple Sclerosis (SUNBEAM and RADIANCE Part B).”

Treatment-related adverse events were reported more frequently in patients treated with Avonex, data in a separate presentation show. In general, serious adverse effects were rare across all study groups in SUNBEAM and RADIANCE, but moderate to severe events were more frequent in Avonex-treated patients.

The most common reported side effects were inflammation of the nasal cavity and pharynx (nasopharyngitis).

Both ozanimod and Avonex showed a similar risk of infection, but no serious opportunistic infections were reported during the studies.

Trial safety data will be presented in the study titled “Safety of Ozanimod Versus Interferon β-1a in Two Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled, Double-Dummy Phase 3 Studies in Relapsing Multiple Sclerosis (SUNBEAM and RADIANCE Part B).”

Taken together, these acceptable tolerability and safety profiles — coupled with ozanimod’s efficacy results — support its potential to be a new therapeutic option with a “favorable benefit-risk profile” for relapsing MS patients, the researchers wrote.

Celgene recently announced that the U.S. Food and Drug Administration had requested more information on ozanimod in regard to a New Drug Application it is considering taking under review. An FDA review of such an application is an essential step in possibly getting an investigative therapy approved for commercial use.