AB Science: authorized by the ANSM to initiate a study to evaluate masitinib in patients with multiple sclerosis

(Boursier.com) – AB Science SA has received authorization from the ANSM to initiate a Phase III study (AB20009) evaluating masitinib in patients with primary progressive multiple sclerosis (PPMS) or non-active secondarily progressive multiple sclerosis (nSPMS). Study AB20009 is titled ‘A 96-Week, Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg / kg / day versus Placebo in the Treatment of Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse ‘.

The study is to recruit 800 patients from many centers with an EDSS (Expanded Disability Status Scale) score between 3.0 and 6.0 and an absence of enhanced T1 brain lesions after injection of gadolinium, measured by MRI (imaging by magnetic resonance). The main objective of the study will be to assess the effect of masitinib on the time to confirmed progression of the disability, the progression being defined as a worsening of one point when the EDSS score at baseline is less than or equal to 5.5, or half a point when the EDSS score at baseline is strictly greater than 5.5, between randomization and week 96.

This confirmatory study follows a first positive phase 2B / 3 study (AB07002) in primary progressive multiple sclerosis (PPMS) and non-active secondarily progressive multiple sclerosis (nSPMS). The results of this study were presented at the 8th joint meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). This study achieved its main objective.

Remember that multiple sclerosis is an autoimmune disease of the central nervous system that affects more than 100,000 people in France and for which no definitive treatment exists to date. It is characterized by a progressive degradation of the nerve cells of the central nervous system by the immune system of patients and comes in two main forms.