AB Science SA announced that it has received authorization from the United States Food and Drug Administration (FDA) to resume patient enrollment in the confirmatory Phase 3 study of masitinib (AB19001) in patients with amyotrophic lateral sclerosis (ALS). Study AB19001 has been authorized in 15 countries in Europe, USA, and other regions and is actively enrolling patients. Study AB19001 is an international, multicenter, randomized, double-blind, placebo-controlled, 3-parallel group, Phase 3 study to compare the efficacy and safety of masitinib in combination with riluzole versus placebo in combination with riluzole for the treatment of people suffering from ALS. The study is intended to confirm the previously published results from the first Phase 2b/3 study (AB10015), which demonstrated that masitinib at 4.5 mg/kg/day in combination with riluzole significantly slowed functional decline by 27% compared with riluzole alone at week 48, as measured by change in ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-revised). Study AB19001 recruitment targets people with ALS that have mild or moderate (non severe) impairment of functionality at baseline. This is closely aligned with the patient population that showed the great survival benefit with masitinib in the long-term survival analysis. The primary endpoint of study AB19001 is absolute change from baseline in functional score as assessed by ALSFRS-R after 48 weeks of treatment.