MediciNova reports additional Phase Ib/IIa data for ibudilast in ALS

MediciNova Inc. (NASDAQ:MNOV; JASDAQ:4875) reported additional data from 51 amyotrophic lateral sclerosis (ALS) patients without non-invasive ventilation in a Phase Ib/IIa trial showing that once-daily 60 mg oral ibudilast (Ketas, AV411, MN-166) plus riluzole non-significantly improved the responder rate vs. placebo plus riluzole (32.4% vs. 11.8%, p=0.1117). A responder was defined as a patient who achieved the composite endpoint of less than a 12-unit decline in ALS Functional Rating Scale-revised (ALSFRS-R) total score at the end of the open-label extension period and less than one manual muscle testing unit decline in neck and/or leg muscles at the end of the open-label extension period. The trial included a six-month, double-blind, placebo-controlled treatment period followed by a six-month open-label extension. Data were presented at the American Academy of Neurology meeting in Los Angeles.

MediciNova previously reported that ibudilast plus riluzole improved ALSFRS-R (29.4% vs. 17.6%, p=0.502) and ALS Assessment Questionnaire (ALSAQ-5) (50% vs. 23.5%) response rates at 6 months vs. placebo plus riluzole. The company pans to discuss next steps with FDA (see BioCentury, Aug. 8, 2016 & Feb. 2, 2018)...