MediciNova announces publication of results of SPRINT-MS trial
MediciNova announced that the New England Journal of Medicine has published results of the SPRINT-MS Phase 2b trial of MN-166 in progressive multiple sclerosis, or MS. The trial included 28 enrolling clinical sites across the U.S. and was designed to evaluate the safety, tolerability and activity of MN-166 administered orally twice daily to subjects with primary progressive or secondary progressive multiple sclerosis. Qualifying subjects were randomly assigned 1:1 to inactive control or MN-166 administered at a dose of up to 100 mg/day. The progressive MS subjects were either untreated with long-term disease modifying therapy or continued on either glatiramer acetate or interferon beta treatment. Hence, randomization was controlled by two factors: therapy status and disease status. The primary objectives of the study were to evaluate the activity of ibudilast versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging analysis for whole brain atrophy using brain parenchymal fraction and evaluate the safety and tolerability of ibudilast versus placebo in subjects with PPMS or SPMS. Additional measures included disability, imaging analyses of brain and retinal tissue integrity, cortical atrophy, cognitive impairment, quality-of-life and neuropathic pain. Exploratory objectives included pharmacokinetic and biomarker analyses.