MediciNova announces Phase 3 clinical trial plan for MN-166
MediciNova announced announced its plans for a Phase 3 clinical trial of MN-166 in progressive multiple sclerosis following feedback from the FDA. Key elements of MediciNova's Phase 3 clinical trial plan for MN-166 in progressive MS include the following: MediciNova's Phase 3 trial will enroll only subjects with secondary progressive MS without relapses. The rationale for enrolling this type of progressive MS is the following: The FDA agreed that a population of subjects with secondary progressive MS without relapses is an appropriate target population. MediciNova believes that subjects with secondary progressive MS without relapses will have the best clinical response to MN-166 treatment, as compared to other types of progressive MS. As MediciNova previously reported in April 2019, results of the subgroup analysis of the SPRINT-MS Phase 2b trial of MN-166 in progressive MS showed that the trends for reduction in the risk of confirmed disability progression, as measured by EDSS, were highest for the subgroup of subjects with secondary progressive MS without relapses, in which MN-166 demonstrated a 46% risk reduction compared to placebo as indicated by the hazard ratio of 0.538. MediciNova believes that the unmet medical need is highest in subjects with secondary progressive MS without relapses as compared to other types of progressive MS. Unlike primary progressive MS and relapsing secondary progressive MS, there are no drugs approved for long-term treatment of secondary progressive MS without relapses. In addition, secondary progressive MS without relapses is the largest subgroup of progressive MS patients. Based on the data from recently completed clinical trials in progressive MS, MediciNova believes that more than 80% of patients with secondary progressive MS do not have relapses. The FDA agreed that the primary endpoint of the Phase 3 trial should be time to 3-month confirmed disability progression, as measured by EDSS. This is the same primary endpoint that was used in the Phase 3 trials of other drugs recently approved for progressive MS. MediciNova plans to conduct a single Phase 3 trial. The FDA acknowledged that a single trial can be the basis for marketing approval and the acceptability of a single trial to support drug approval depends on the study results. The two drugs approved for relapsing secondary progressive MS in March 2019 were approved by the FDA after conducting a single Phase 3 trial.