Investigational MS drug lowers the relapse rate during a phase 3 clinical trial.
The investigational drug ozanimod was found to reduce the frequency of multiple sclerosis (MS) relapse in a new phase 3 study.
Ozanimod acts as a sphingosine 1-phosphate 1 (S1PR1) receptor agonist to modulate S1PR1 signaling and blocks the sources of inflammation.
The randomized, double-blind, double-dummy, active-controlled, phase 3 SUNBEAM study examined ozanimod compared with interferon β-1a (Avonex) in patients with relapsing MS. Included in the study were 1346 individuals.
The results of the study showed that ozanimod met its primary endpoint in reducing the annualized relapse rate of relapsing MS compared with Avonex.
Ozanimod was administered at doses of 1 mg and 0.5 mg, and demonstrated statistically significant and clinically meaningful improvements for the primary endpoint of ARR compared with Avonex.
Additionally, the drug demonstrated improvements with the measured secondary endpoints of the number of MRI-detected lesions and the number of new or enlarging T2 MRI lesions after 1 year of treatment.
“It is exciting and rewarding to see the results of this new phase 3 trial, which confirm the safety profile from the 2-year extension data from the phase 2 RADIANCE study and underscore oxanimod’s efficacy in reducing the burden of MS symptoms on patients and their families,” said investigator Hugh Rosen. “We look forward to seeing the full study results, as well as the results from the phase 3 study evaluating ozanimod in patients with ulcerative colitis.”
Ozanimod is the first New Clinical Entity discovered from a starting point in the National Institutes of Health Common Fund Molecular Libraries Initiative to reach and succeed in advanced clinical studies.