An investigational oral drug for multiple sclerosis (MS), called ONO-4641, reduced the number of lesions detected on magnetic resonance imaging (MRI) scans
New Orleans, LA—An investigational oral drug for multiple sclerosis (MS), called ONO-4641, reduced the number of lesions detected on magnetic resonance imaging (MRI) scans, according to the results of the double-blind, phase II DreaMS trial presented at the American Academy of Neurology’s 64th Annual Meeting. ONO-4641 is a potent oral and selective sphingosine-1 phosphate receptor agonist.
The dose-finding study included 407 patients with relapsing-remitting MS who were randomized to receive ONO-4641or placebo for 26 weeks. Patients receiving ONO-4641 were given 0.05 mg, 0.10 mg, or 0.15 mg once daily.
Patients were eligible for the study if they had 2 or more relapses in the past 2 years, 1 or more relapses within the year prior to the study, or 1 or more new gadolinium (Gd)-enhancing brain lesions detected on MRI within the previous 3 months. MRI scans were performed every 4 weeks. The study’s primary end point was cumulative number of T1 Gd-enhancing lesions from week 10 to week 26.
“ONO-4641 demonstrated statistically significant efficacy on key end points, compared with placebo, and was well tolerated in patients with relapsing-remitting MS,” announced Timothy Vollmer, MD, University of Colorado in Denver.
Compared with patients given placebo, those receiving ONO-4641 had significant reductions in MRI lesions: 82% fewer with 0.05 mg, 92% fewer with 0.10 mg, and 77% fewer with 0.15 mg of the drug.
Averse events appeared to be dose-related and included cardiovascular changes (eg, lower heart rate, blood pressure changes, and atrioventricular block). Other adverse events included elevations in liver enzymes and lymphopenia; grade 4 lymphopenia was observed in 4% of patients receiving 0.15 mg per day, and in 1% of patients receiving 0.10 mg per day.
“In light of recent issues in the oral MS drug market, this is welcome news,” Dr Vollmer commented.
The study was supported by Ono Pharmaceutical Co, Ltd.