Tuesday, April 17 (HealthDay News) -- As part of a Phase 2 trial, Timothy Vollmer, M.D., 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 (0.05 mg, 0.10 mg, or 0.15 mg) once a day for 26 weeks. Participants were aged 18 to 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 percent for the 0.05 mg dose, 92 percent for the 0.10 mg dose, and 77 percent for the 0.15 mg 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.