MediciNova 'excited' with results of SPRINT-MS Phase 2b trial subgroup analysis
MediciNova announced results from its subgroup analysis of the SPRINT-MS Phase 2b trial of MN-166 in progressive multiple sclerosis. This subgroup analysis was conducted based on recent feedback MediciNova received from the FDA that relapsing secondary progressive MS is different from non-relapsing secondary progressive MS as non-relapsing secondary progressive MS is the only type of secondary progressive MS without available therapy. The purpose of the subgroup analysis was to provide information about which types of progressive MS subjects responded best to MN-166 treatment in terms of the clinically significant endpoint of the risk of confirmed disability progression compared to placebo, as measured by EDSS. Confirmed disability progression was a secondary endpoint in this Phase 2b trial but would be considered a primary endpoint in Phase 3. Unlike the magnetic resonance imaging endpoint of whole brain atrophy, which is not a clinical endpoint, confirmed disability progression is the most important clinical endpoint and is the basis for FDA approval of progressive MS drugs. The trends for reduction in the risk of confirmed disability progression were highest for the subgroup of subjects with Secondary Progressive MS without Relapse, in which MN-166 demonstrated a 46% risk reduction compared to placebo as indicated by the hazard ratio of 0.538. Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc. commented, "We are excited with the results of our subgroup analysis. Although two drugs have recently received FDA approval for relapsing secondary progressive MS, there remains a very large unmet medical need for secondary progressive MS patients without relapses as there is still no drug approved for long-term treatment of these patients. Based on our extensive analysis of the SPRINT-MS data including this subgroup analysis, we are finalizing the optimal trial design for what we believe will be a very successful Phase 3 program and we plan to submit this trial design to the FDA shortly. With a convenient oral administration, a very favorable safety and tolerability profile, and the potential for better efficacy than other drugs for progressive MS, we believe ibudilast could become the best-in-disease drug."