MediciNova Announces Clinical Data from Subgroup Analyses of Completed Clinical Trial of MN-166 (ibudilast) in ALS

MediciNova a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (TSE:4875), today announced clinical data from ad-hoc subgroup analyses of MediciNova’s completed clinical trial of MN-166 (ibudilast) in ALS (amyotrophic lateral sclerosis), which was conducted at Carolinas HealthCare System’s Neuromuscular/ALS-MDA Center at Carolinas HealthCare System Neurosciences Institute.

As quoted in the press release:

The ad-hoc subgroup analyses include data from (1) the “Early ALS subgroup” which is 31 subjects who had either bulbar onset or upper limb onset out of a total of 49 subjects without non-invasive ventilation in the full analysis set and (2) the “Early ALS + NIV subgroup” which is 39 subjects who had either bulbar onset or upper limb onset out of a total of 67 subjects with and without non-invasive ventilation in the full analysis set. The full analysis set includes all randomized subjects who received at least 14 days of study drug and had at least one post-dose efficacy measurement. The subgroup analyses were completed for the ALSFRS-R total score, the ALSAQ-5 score, and the Manual Muscle Test. A responder was defined as a subject who did not worsen on the score (i.e., the subject improved on the score or had no change on the score) at the end of the 6-month double-blind period. Results of the subgroup analyses are as follows:

Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Total Score

ALSFRS-R, which includes 12 questions that can have a score of 0 to 4, measures functional activity and has been useful in diagnosing and measuring disease progression.

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