Masitinib Marketing Application for ALS Accepted by European Medicines Agency

Masitinib Marketing Application for ALS Accepted by European Medicines Agency

AB Science recently announced that the European Medicines Agency (EMA) has accepted a conditional marketing authorization application for the tyrosine kinase inhibitor masitinib to treat amyotrophic lateral sclerosis (ALS).

AB Science develops protein kinase inhibitors (PKIs), a class of targeted proteins that are key for signaling pathways within cells. It has been shown that blocking selected cell signaling pathways through PKIs could have therapeutic benefits in cancers, inflammatory diseases, and diseases of the central nervous system (CNS).

Masitinib is an orally administered therapy that targets mast cells and macrophages, important cells for immunity, by inhibiting a limited number of kinases.

The drug candidate has a unique mechanism of action. In oncology, because of its immunotherapy effect, masitinib can have an effect on survival, by itself or in combination with chemotherapy. Because of its activity on mast cells and the subsequent inhibition of the inflammation process, masitinib can be effective against symptoms of inflammatory and CNS-associated diseases.

The full review process started on Sept. 12. Filing for the marketing authorization of masitinib in ALS was grounded on positive results from the predefined interim analysis of the Phase 2/3 clinical trial AB10015 (NCT02588677).

The trial was a double-blind, placebo-controlled study that compared the effectiveness and safety of masitinib in combination with riluzole, versus placebo in combination with riluzole, for the treatment of ALS.

The filing also included preclinical data showing neuroprotective effects of masitinib in ALS, through the targeting of microglial cells. The data was published in the Journal of Neuroinflammation in the report “Post-paralysis tyrosine kinase inhibition with masitinib abrogates neuroinflammation and slows disease progression in inherited amyotrophic lateral sclerosis.”

Based on the same results, masitinib was designated an Orphan Drug by EMA’s Committee for Orphan Medicinal Products (COMP).

According to the press release, EMA’s decision on registering masitinib in ALS should be made public during the second half of 2017.

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