AB Science reports masitinib data in Phase II/III ALS trial

AB Science S.A. (Euronext:AB) reported additional data from the double-blind, Spanish Phase II/III Study AB10015 suggesting that the higher of 2 doses of oral masitinib (Masican, Masiviera) (AB1010) significantly slowed the progression of amyotrophic lateral sclerosis (ALS) vs. placebo in a subgroup of patients with more slowly progressing disease at baseline.

In March, the company said once-daily 4.5 mg/kg oral masitinib as an add-on to riluzole met the primary endpoint of improving ALS Functional Rating Scale-Revised (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 (see BioCentury, April 18, 2016 & March 27, 2017). On May 18, the company presented the data at the European Network for the Cure of ALS meeting in Ljubljana, Slovenia...