Masitinib: Additional Ph II/III Study AB10015 data

The double-blind, Spanish Phase II/III Study AB10015 in 394 ALS patients showed that once-daily 4.5 mg/kg oral masitinib as an add-on to riluzole met the primary endpoint of improving ALSFRS-R score from baseline to week 48 vs. placebo plus riluzole (p=0.014). Patients received riluzole plus placebo or once-daily 3 or 4.5 mg/kg masitinib. AB Science said a stepwise sequence of analysis was predefined in the trial to first test the higher dose of masitinib vs. placebo and then the lower dose vs. placebo. The company said low-dose masitinib plus riluzole showed a trend toward improving ALSFRS-R score from baseline to week 48 vs. placebo plus riluzole. High-dose masitinib plus riluzole also met the secondary endpoints of improving PFS (p=0.016) and QOL as measured by the ALS Assessment Questionnaire (ALSAQ) score (p<0.01) vs. placebo plus riluzole. Low-dose masitinib plus riluzole showed a trend towards improving PFS, but significantly improved QOL vs. placebo plus riluzole (p<0.01). Neither dose of masitinib significantly improved OS vs. placebo...