AB Science presented the results of the interim analysis of the study of masitinib in ALS.
The planned enrolment was 381 patients, with a pre-planned futility analysis with 30% of patients enrolled treated for 48 weeks, and a pre-planned interim analysis with 50% of patients enrolled treated for 48 week.
The interim analysis was based on 192 patients in 3 arms, equivalent to 64 patients per arm. Each items of the pre-planned interim analysis are positve. Please read all results reported by AB Science.
Based on the outcome of interim analysis, AB Science will initiate discussion with EMA and FDA regarding the possibility to file for marketing authorization.
The study is not stopped at this time and follow- up data will be available
in Q1 2017.