AAN: Drug Reduces Brain Lesions in Multiple Sclerosis
(HealthDay News) – An experimental drug, ONO-4641, which is an oral sphingosine-1-phosphate receptor agonist, reduces the number of brain lesions in patients with relapsing-remitting multiple sclerosis (MS).
As part of a Phase 2 trial, Timothy Vollmer, MD, from the University of Colorado in Denver, and colleagues randomly assigned 407 patients with relapsing-remitting MS to placebo or one of three doses of ONO-4641 (0.05mg, 0.1mg, or 0.15mg) once a day for 26 weeks. Participants were aged 18–55 years and had Expanded Disability Status Scale scores up to 5.5.
Based on brain scans performed every four weeks starting at week 10, the researchers found that, compared with placebo, there was a reduction in gadolinium-enhancing lesions of 82% for the 0.05mg dose, 92% for the 0.1mg dose, and 77% for the 0.15mg dose. Adverse events appeared to be dose related and included cardiovascular events, liver enzyme elevations, and grade 4 lymphopenia.
"ONO-4641 demonstrated statistically significant efficacy on key end points, compared to placebo, and was well tolerated in patients with relapsing-remitting MS," Vollmer and colleagues conclude.
The study was supported by Ono Pharmaceutical Co., Ltd., which developed ONO-4641.