MediciNova confirms Phase 3 trial of ibudilast in progressive MS

Ibudilast could be the best-in-disease drug for MS patients with unmet medical needs

MediciNova, Inc., a biopharmaceutical company that develops novel therapeutics and is traded on Tokyo Stock Exchange’s JASDAQ Market and on NASDAQ Global Market, recently announced the plans for a Phase 3 clinical study of MN-166 (ibudilast) in progressive multiple sclerosis patients after a feedback from the U.S. Food and Drug Administration (FDA).

Apparently, Phase 3 clinical trial of MediciNova will be enrolling subjects who are suffering from secondary progressive multiple sclerosis without relapses. It is MediciNova’s believe that subjects who have secondary progressive MS without any relapses will give the best response clinically to MN-166 treatment compared to any other type of progressive MS.

According to previous reports by MediciNova, MN-116’s SPRINT-MS Phase 2b trial in progressive MS depicted that the reduced risks of confirmed disability progression trend, as EDSS measured, is the highest for the subjects put in a subgroup suffering from secondary progressive MS sans relapses. MN-166 (ibudilast) showed a risk reduction of 46% as compared to placebo, indicated by 0.538 of hazard ratio.

Reportedly, for long-term secondary progressive treatment MS sans relapses, that is the largest subgroup of patients with progressive MS, there is no approved drugs as compared to primary and secondary progressive relapses. Following the conclusion of recently finished progressive MS’ clinical trial, MediciNova has found that over 80% of patients who have secondary progressive MS do not suffer from relapses.

MediciNova’s President and Chief Executive Officer, Yuichi Iwaki, MD, PhD., said that despite the approval of FDA given for two drugs, there has been significant unmet medical need for patients with secondary progressive MS without any relapses. The company believes ibudilast can become the best-in-disease drug with favorable safety, tolerability and convenient oral administration.

The National MS society reports that MS affects nearly 2.3 million people globally, where around 85% of patients are diagnosed with relapsing remitting MS initially.

 

Source credit- https://investors.medicinova.com/news-releases/news-release-details/medicinova-announces-phase-3-clinical-trial-plan-mn-166