MediciNova completes patient enrolment in Phase IIb trial of MN-166 to treat progressive MS

A total of 255 subjects have been enrolled, which exceeds the goal of 250 subjects that were planned for participation.

The National Institute of Neurological Disorders and Stroke (NINDS) will conduct an interim efficacy analysis after half the subjects complete the 96-week treatment period, which analysis is expected to occur in fall next year.

MediciNova president and chief executive officer Yuichi Iwaki said: "We are very pleased to have exceeded the enrollment target in this important study.

"The unmet medical need for progressive MS patients is extremely high as there is no treatment approved for long-term use for these patients. We look forward to providing further updates as the study progresses."

The Phase II SPRINT-MS trial involves 28 enrolling clinical sites across the US and is designed to evaluate the safety, tolerability and efficacy of MN-166 (ibudilast) administered twice daily to subjects with primary or secondary progressive multiple sclerosis (PPMS or SPMS, respectively).

All 255 qualifying subjects are randomly assigned 1:1 to inactive control (placebo) or MN-166 (ibudilast) administered at a dose of up to 100mg/day (50mg twice daily).

The trial’s primary objectives are to evaluate the activity of ibudilast (MN-166) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF) as well as assess the safety and tolerability of ibudilast (MN-166) versus placebo administered orally in subjects with PPMS or SPMS.

Secondary measures of the trial include disability, imaging analyses of brain and retinal tissue integrity, cortical atrophy, cognitive impairment, quality-of-life and neuropathic pain.