Celgene said its phase III RADIANCE trial of oral drug ozanimod decreased the calculated relapse rate in patients with relapsing multiple sclerosis (RMS).
Multiple sclerosis (MS) is an immune disease affecting the protective myelin sheath covering the nerves, disrupting communication between the brain and the body. MS affects an estimated 400,000 people in the United States and 2.5 million people globally. RMS is the occurrence of defined attacks of worsening neurologic function. These attacks or relapses are followed by partial or complete recovery periods (remissions), during which symptoms improve partially or completely, and there is no apparent progression of the disease.
"The results of phase III RADIANCE trial confirm the data observed in SUNBEAM and are consistent with the long-term phase III RADIANCE trial," Bruce Cree, associate professor of neurology, Multiple Sclerosis Center, University of Califonia, San Francisco, said in a Celgene release.
The RADIANCE and SUNBEAM phase III trials were randomized, double-blind, double dummy, active-controlled tests consisting of two doses of oral ozanimo against a weekly intramuscular interferon beta-1a (Avonex) over a two-year treatment period, the release said. The RADIANCE trial consisted of 1,313 RMS patients at 147 sites in 21 countries. The SUNBEAM trail studied 1,346 RMS patients at 152 sites n 20 countries.
A low rate of disability progression was observed across the three treatment groups, and ozanimod did not reach statistical significance compared to Avonex. Each dose of ozanimod displayed a statistically significant reduction in brain atrophy compared to Avonex in each phase III trial, the release 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," Terrie Curran, president of Celgene Inflammation and Immunology, said in the release.
A new drug application is expected to be submitted to the U.S. Food and Drug Administration by the end of 2017, the release said.