EMA Recommends Filing for Masitinib Conditional Marketing Authorization to Treat ALS
Rapporteurs appointed by the European Medicines Agency (EMA) have recommended that AB Science SA’s combined treatment ‘masitinib with riluzole’ in the treatment of adults with amyotrophic lateral sclerosis (ALS) should be filed for conditional marketing authorization.
AB Science specializes in developing and marketing protein kinase inhibitors (PKIs), a class of targeted proteins critical to signaling pathways within cells. The pharmaceutical has developed a proprietary portfolio of molecules and the company’s lead compound masitinib, is already registered for veterinary medicine in Europe and the U.S.
The company is currently conducting 12 Phase 3 clinical studies in humans for the treatment of several conditions, including progressive diseases like ALS.
Masitinib is a novel, orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, key cells for immunity, by inhibiting a limited number of kinases. Masitinib has a unique mechanism of action that can be developed in oncology, inflammatory diseases and in some conditions of the central nervous system.
The filing request is grounded on clinical data from the Phase 2/3 clinical study AB10015. According to a press release, its shows promising results on its pre-specified primary endpoint at the interim assessment and on its preclinical data of masitinib on ALS.
Three pre-submission meetings held in May, reviewed the study’s clinical relevance of the treatment effect; design compliance with the EMA guidance on ALS clinical trials; absence of bias; the safety profile based on frequency of adverse events; the convergence of treatment effects on secondary analyses, including quality-of-life. Also reviewed was the status of data availability; the consistency of sensitivity analyses on the primary analysis; the resolution of any objections regarding the manufacturing process raised by EMA during the previous evaluation in GIST and plausibility of the mechanism of action of masitinib in ALS.
The company is expected to submit the application for conditional marketing authorization of masitinib in combination with riluzole for the treatment of adult ALS patients, by the end of the third quarter of 2016.