AB Science has recently received approval from the US Food and Drug Administration (FDA) to begin a phase 3 clinical trial with the drug mastinib, intended for the treatment of multiple sclerosis (MS), according to a recently published press release.

Primary progressive multiple sclerosis (PPMS) and nonactive secondary progressive multiple sclerosis (nSPMS) represent approximately 35% of multiple sclerosis cases globally. However, to this date, there is only one approved treatment for PPMS and none for nSPMS
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Masitinib intends to treat both PPMS and nSPMS by acting as a tyrosine kinase inhibitor in mast cells and microglia. Its mechanism of action appears to be complementary to other tyrosine kinase inhibitors proposed for treating MS.

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FDA approval is based on the results from the previous phase 2B/3 study AB07002, which revealed that masitinib reduced the loss of functional capacity measured by the Expanded Disability Status Scale (EDSS).

Furthermore, according to the results of the trial, masitinib can reduce the risk of first disability progression by approximately 40% and the risk of 3 months of disability progression by over 35%. Unlike other similar drugs, masitinib was not associated with a significantly higher risk of infection.

The randomized, double-blind, phase 3 AB20009 study is currently in its recruitment phase and aims to recruit 800 patients. Patients must have an EDSS score between 3.0 and 6.0; patients with the presence of T1 gadolinium-enhancing brain lesions will be excluded. The primary endpoint of the study will be the capacity of masitinib to prevent confirmed disability progression.

“This demonstrates interest from the health authorities in the masitinib program in progressive forms of multiple sclerosis and more broadly in neurodegenerative diseases, and also their acknowledgement that masitinib has viable neuroprotective role via its mechanism of action, which we believe is supported by the scientific and clinical data,” said Patrick Vermersch, MD, principal investigator of the study and professor of neurology at the University of Lille in France.

Reference

AB Science has received approval from the U.S. Food and Drug Administration (FDA) to initiate the confirmatory phase 3 study with masitinib in the treatment of progressive multiple sclerosis. News release. AB Science; December 29, 2022.