AB Science announces new publication on Medrxiv highlighting clinical benefit with masitinib in Amyotrophic Lateral Sclerosis patients prior any complete loss of function

Core Insights - AB Science announced a new publication on MedRxiv detailing the clinical benefits of masitinib for amyotrophic lateral sclerosis (ALS) patients before any complete loss of function [2][3] Group 1: Study Findings - The post-hoc subgroup analysis from the phase 2b/3 AB10015 study shows significant improvement in functional decline measured by the ALSFRS-R score, with a 4.04-point difference favoring masitinib over placebo (p=0.0065) [4][5] - A relative benefit of +20.2% on the CAFS score was observed compared to placebo (p=0.0290), surpassing the +13.8% benefit seen in the primary analysis [5] - Median progression-free survival (PFS) was extended by 9 months (p=0.0057) and median overall survival (OS) increased by 12 months (p=0.0192) compared to placebo, both improvements being more pronounced than those in the primary analysis [5] Group 2: Safety and Patient Population - Safety outcomes improved, with a reduction in serious adverse events from 27.6% to 22.6% in masitinib-treated patients [5] - The subgroup analyzed included patients with a score of at least 1 on all ALSFRS-R items at baseline, representing approximately 85% of the primary analysis population [3][5] Group 3: Future Studies - The findings from this analysis will inform the design of the confirmatory study AB23005, which targets patients prior to any complete loss of function to optimize the benefit-risk balance [2][3] - Study AB23005 is a prospective, multicenter, randomized, double-blind, placebo-controlled trial involving 408 ALS patients, aiming to confirm the efficacy and safety of masitinib [7][8]