Results of Phase 3 Trial for Celgene’s Ozanimod Suggest Therapeutic Benefit in RMS Patients
Relapsing multiple sclerosis (RMS) patients taking the investigational drug ozanimod, also known as RPC-1063, had lower relapse rate than those on weekly Avonex (interferon β-1a) therapy, according to Celgene in an announcement updating results of its Phase 3 RADIANCE trial.
Ozanimod is a new orally administrated drug that selectively inhibits the S1PR1 and S1PR5 receptors — both of which are involved in immune cells’ response to inflammation as well as the activation of a specific subset of cells of the central nervous system. That means ozanimod can potentially prevent inflammation as well as neurological damage.
The RADIANCE (NCT02047734) study to evaluate the safety and efficacy of ozanimod involved 1,313 RMS patients across 147 sites in 21 countries. Participants received either oral ozanimod (0.5 mg or 1 mg) daily, weekly intramuscular injection of Avonex, or placebo for a period of two years.
Both ozanimod tested doses showed statistically significant and clinically meaningful reductions in the pre-established study primary endpoint of annualized relapse rate. The therapy also reduced the number and size of MRI-detected lesions compared to Avonex.
Using data collected by the RADIANCE and SUNBEAM (NCT02294058) Phase 3 trials, researchers — under an agreement with the U.S. Food and Drug Administration (FDA) — evaluated the time it took for patients to progress to confirmed disability. They observed a very low rate of disability progression across all three treatment groups, with no significant difference between ozanimod and Avonex. Some investor sites also noted that a pooled Phase 2 and 3 trial analysis failed to show statistically significant disability improvement between ozanimod- and Avonex-treated patients.
However, ozanimod in the Phase 3 data was shown to significantly reduce brain atrophy compared to standard care with Avonex in both trials.
Ozanimod’s overall safety and tolerability profile was consistent with previous results reported from the Phase 2 and 3 trials.
“The results of the Phase III RADIANCE trial confirm the data observed in SUNBEAM and are consistent with the long-term Phase II RADIANCE trial,” neurology professor Bruce Cree of the University of California San Francisco’s Multiple Sclerosis Center said in a news release. “The significant effects seen with ozanimod on relapse and MRI outcomes, including brain volume loss, coupled with the safety and tolerability profile observed in the two Phase III trials, represent an exciting advancement for a disease which needs additional oral therapies with favorable benefit-risk profiles.”
Further analyses of data collected in the RADIANCE trial are ongoing and will be presented at an upcoming medical congress.
Combined results of SUNBEAM and RADIANCE trials are expected to support Celgene’s new drug application (NDA) submission to the FDA by year’s end for ozanimod to treat RMS.
“We are excited by the results seen to-date across both pivotal trials, which further validated ozanimod’s promising benefit-risk profile relative to current therapies,” said Terrie Curran, president of Celgene Inflammation and Immunology. “We plan to begin submitting global registration dossiers by the end of the year to bring this oral therapy to patients with relapsing multiple sclerosis.”