Analysis showed oral ozanimod reduced brain volume loss across all age subgroups in adults with relapsing multiple sclerosis

Celgene Corporation announced the results of a post-hoc analysis of data from the Phase III RADIANCE Part B trial showing that ozanimod reduced cortical grey matter volume loss versus first-line treatment, Avonex (interferon beta-1a), in adults with relapsing multiple sclerosis (RMS) across all age groups, including patients ages 18 to 25. The analysis will be presented at the 2019 American Academy of Neurology (AAN) Annual Meeting in Philadelphia, May 4-10, 2019.

“Brain volume loss is associated with long-term physical disability and cognitive issues in multiple sclerosis,” said Bruce Cree, M.D., Ph.D., M.A.S., Professor of Neurology at the University of California San Francisco (UCSF) Weill Institute for Neurosciences, Clinical Research Director at the UCSF MS Center, and an author of the analysis. “Ozanimod reduced the loss of cortical grey matter volume across all age groups in this study.”

RADIANCE evaluated two doses of oral ozanimod (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI respectively) compared with interferon beta-1a in 1,313 patients with RMS between the ages of 18 and 55 years old. In this post-hoc analysis of 874 patients, treatment effect on serial brain volume, including thalamic volume and cortical grey matter, was evaluated by patient age (18 to 25, n=146; 26 to 34, n=265; 35 and older, n=463) at baseline, 12 months and 24 months. Patients in the 18 to 25 age group tended to have greater brain volume at baseline but more active disease as measured by gadolinium-enhancing MRI lesions. There was also a trend for this age group to experience greater whole brain volume loss at both 12 and 24 months compared with the older groups. Patients across all age groups treated with ozanimod lost less cortical grey matter volume than did those treated with interferon beta-1a over 24 months, including patients in the 18 to 25 age group. In the RADIANCE Part B trial, the most common adverse reactions (greater than 5 percent) that were higher with ozanimod than with interferon beta-1a were upper respiratory tract infections, urinary tract infections, increases of alanine aminotransferase and increases of gamma-glutamyl transferase. Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). Ozanimod is an investigational compound that is not approved for any use in any country.