ARTICLE | Clinical News

MediciNova reports additional Phase II data for ibudilast in ALS

February 2, 2018 8:25 PM UTC

MediciNova Inc. (NASDAQ:MNOV; JASDAQ:4875) reported data from 51 evaluable amyotrophic lateral sclerosis (ALS) patients without non-invasive ventilation in a Phase II trial showing that once-daily 60 mg oral ibudilast (Ketas, AV411, MN-166) plus riluzole improved ALS Functional Rating Scale-revised (ALSFRS-R) (29.4% vs. 17.6%) and ALS Assessment Questionnaire (ALSAQ-5) (50% vs. 23.5%) response rates at 6 months vs. placebo plus riluzole. MediciNova could not be reached for p-values on the endpoints or next steps for ibudilast to treat ALS. The company also said the double-blind, U.S. trial met its primary endpoint of safety. Data were presented at the International ALS/MND Symposium in Boston in December.

Secondary endpoints in trial include slow vital capacity (SVC), maximum inspiratory pressure (MIP), forced expiratory volume in 1 second (FEV1), muscle strength and non-invasive ventilation utilization. MediciNova previously reported interim data from the trial (see BioCentury, Aug. 8, 2016)...