This analysis was aimed to understand the types of progressive MS subjects that responds best to MN-166 (ibudilast) treatment
MediciNova, Inc., the biopharmaceutical firm listed on the Tokyo Stock Exchange’s JASDAQ Market and NASDAQ Global Market, has reportedly announced outcomes of the SPRINT-MS Phase 2b trial of MN-166 (ibudilast) in progressive MS (progressive multiple sclerosis) from its subgroup analysis.
According to the press release by MediciNova, the subgroup analysis was focused on the recently received feedback from the Food and Drug Administration (FDA) that relapsing secondary progressive MS (secondary progressive MS with relapse) is in contrast to Secondary Progressive MS without Relapse (non-relapsing secondary progressive MS) as there is no available therapy for non-relapsing secondary progressive MS.
This analysis was aimed to understand the types of progressive MS subjects that responds best to MN-166 (ibudilast) treatment regarding the clinically substantial endpoint of the risk of confirmed disability progression in comparison with placebo, as determined by EDSS. In this Phase 2b trial, it was analyzed that confirmed disability advancement was a secondary endpoint but will be measured a primary endpoint in Phase 3. It was confirmed that disability progression is a vital clinical endpoint and progressive MS drugs’ approval from FDA is based on this validation.
There were maximum trends for decrease in the threat of confirmed disability advancement for the subgroup of subjects with, in which a risk reduction of 46% was demonstrated by MN-166 (ibudilast) and was specified by the hazard ratio of 0.538 as compared to placebo.
There is huge market prospect to treat Secondary Progressive MS without Relapse as most patients with secondary progressive MS lack relapses. Although there exists huge market prospect, there is no approved drug available for the long-term treatment of patients suffering from Secondary Progressive MS without Relapses.
