AB Science SA announced that it has received the first authorization to resume patient enrollment in the confirmatory Phase 3 study of masitinib (AB19001) in amyotrophic lateral sclerosis (ALS). This authorization from a national competent authority follows the submission of an amended protocol for the AB19001 study which includes a new risk management plan to strengthen cardiac safety. This first authorization comes from a European national agency, namely Norway. As a reminder, 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 patients 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 Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) decline by 27% compared to riluzole alone at week 48 (p-value < 0.05). Study recruitment targets people with ALS that have mild or moderate impairment of functionality at baseline. This is closely aligned with the patient population that showed the 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.