(Boursier.com) — AB Science announces that it has received approval from the US Food and Drug Administration (FDA) to initiate the confirmatory Phase 3 study with masitinib in the treatment of progressive forms of multiple sclerosis.
This decision follows the authorizations received from several European countries, including the French Medicines Agency (ANSM). This authorization to start a confirmatory study in neurology is the third obtained from the FDA after the studies in Amyotrophic Lateral Sclerosis (AB19001) and Alzheimer’s disease (AB21004).
This AB20009 study is in the active recruitment phase. This is a phase 3 randomized double-blind study aimed at evaluating the safety and efficacy of masitinib administered at a dose of 4.5 mg/kg/day in patients with primary progressive multiple sclerosis ( PPMS) or non-active secondary progressive multiple sclerosis.
The study should recruit 800 patients and its primary endpoint is the effect of masitinib on the time to confirmed disability progression. Its objective is to confirm the positive results of the phase 2B/3 study (AB07002).
AB Science recalls that masitinib is positioned in the progressive forms of the disease and that there is currently only one treatment for the primary progressive forms and none for the non-active secondary progressive forms, which respectively represent approximately 15% and 35% of multiple sclerosis cases, or approximately 500,000 patients in the United States and Europe.
Masitinib targets microglia and mast cells, which are two cells of the innate immune system associated with the pathology of progressive forms of multiple sclerosis. Masitinib’s mechanism of action is different and potentially complementary to other tyrosine kinase inhibitors under development in multiple sclerosis, which are BTK inhibitors that target microglia and B cells.
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