This is a summary of a press release by MediciNova, Inc.
According to MediciNova's announcement, MN-166 (ibudilast) will move on to Phase III clinical trials on progressive multiple sclerosis (MS).
President and Chief Executive Officer of MediciNova, Inc., Yuichi Iwaki, MD, PhD, said, 'We are excited to announce our Phase 3 plan for MN-166 for progressive MS. 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 the vast majority of secondary progressive MS patients do not have relapses and there is still no drug approved for long-term treatment of these patients.'
The press release states that the main elements from the trial are that:
- MediciNova’s Phase III trial will enrol only subjects with secondary progressive MS without relapses as this group has the highest risk reduction of confirmed disability progression.
- The FDA agreed that the primary endpoint of the Phase III trial should be time to 3-month confirmed disability progression, as measured by EDSS (Expanded Disability Status Scale). 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 III 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 (or 'active') secondary progressive MS in March 2019 were approved by the FDA after conducting a single Phase III trial.
MediciNova. MediciNova Announces Phase 3 Clinical Trial Plan for MN-166 (ibudilast) in Progressive MS. 11/07/2019