AB Science S.A. announced publication of a paper titled Long-term Survival Analysis of Masitinib in Amyotrophic Lateral Sclerosis in the peer-reviewed journal Therapeutic Advances in Neurological Disorders (TAND). The publication represents completely new data reporting long-term survival analysis of masitinib as an add-on therapy to riluzole in patients with amyotrophic lateral sclerosis (ALS) from the randomized clinical trial AB10015. The survival analysis followed all patients originally randomized in study AB10015 for an average duration of 75 months from the date of diagnosis. In ALS patients with mild or moderate disease severity at baseline, it was seen that treatment with 4.5 mg/kg/day masitinib (n=50) as an add-on to standard riluzole prolonged survival by 25 months relative to those treated with riluzole alone (n=63) (median OS of 69 versus 44 months, respectively, P=0.037) with a 44% reduced risk of death. People with mild or moderate ALS comprised patients that had not suffered a complete loss or severe impairment of ALSFRS-related functionality at the time of masitinib treatment initiation (i.e., patients with a score of at least 2 on each ALSFRS-R individual component). This population corresponds closely to the patient cohort enrolled in confirmatory phase 3 study, AB19001. These survival data were corroborated by the effect observed in the endpoints of ?ALSFRS-R at week-48 and progression-free survival (PFS, a time-to-event analysis) for this cohort of patients, further supporting the premise of greater treatment effect when masitinib is initiated at an earlier stage of disease. Consistent with results previously communicated on study AB10015, no long-term survival advantage was observed for the overall masitinib 4.5 mg/kg/day cohort of study AB10015 (i.e., regardless of baseline disease severity or post-onset ALSFRS-R progression rate) or for the low-dose (3.0 mg/kg/day) masitinib treatment-arm. These long-term survival results are consistent with masitinib’s mechanism of action, which significantly slows microglial-related disease progression, and prevents mast cell-related neuromuscular junctions denervation and Schwann cell meditated neuroinflammation. Based on this mechanism of action, it is expected that masitinib would provide better outcomes if administered early in disease progression when the larger motoneurons innervating type IIb fibers are still functioning and capable of sprouting terminal branches to reinnervate previously denervated endplates (improved sprouting capacity would maintain motor function longer and slow the ALSFRS-R decline). 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 greatest 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.