Celgene announced positive results from ‘Radiance’, the Phase 3 trial of ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, for patients with relapsing multiple sclerosis (RMS).
The Radiance trial included 1,313 relapsing multiple sclerosis (RMS) patients who were administered either 0.5mg or 1mg of oral ozanimod, or weekly intramuscular interferon beta-1a (Avonex) over a 2 year treatment period.
Both ozanimod doses showed statistically significant and clinically meaningful reductions in the primary endpoint of annualized relapse rate and in the secondary endpoints of the number of new or enlarging T2 MRI lesions over 24 months of treatment compared to Avonex and the number of gadolinium-enhancing MRI lesions at 24 months of treatment compared to Avonex.
“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,” said Bruce Cree, MD, PhD, of UC, San Francisco.
Additionally, safety results were positive and shown to be in line with those from ‘Sunbeam’, a recently completed Phase 3 trial evaluating ozanimod in comparison to Avonex.
Results from both Radiance and Sunbeam will be presented in further detail at an upcoming medical congress. Terrie Curran, president of Celgene said, “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.”
For more information visit Celgene.com.