AB Science withdrew its appeal to the European Medicines Agency (EMA) over its decision to reject the approval of masitinib for the treatment of ALS (see April 2018 news).
The decision announced by AB Science on May 28, is based in part on the inability to provide additional data during this “re-examination” procedure. These results include findings from the phase 3 clinical trial examining the safety of masitinib and additional preclinical analysis to further elucidate its mechanism of action.
AB Science is now considering resubmitting its application, including these findings, to make its case for the drug as a treatment for the disease.
The EMA voted against the approval of masitinib as a treatment for ALS last April based in part on concerns about the phase 3 clinical trial results and their subsequent analysis (see June 2017 news).
Masitinib aims to slow progression of ALS by reducing microglia-based inflammation of neurons in the brain and spinal cord (Trias et al., 2016).
A second phase 3 clinical trial is planned. The study is anticipated to begin in the fall of 2018. The clinical trial is to take place in the US and Canada. Montreal Neurological Institute and Hospital’s Angela Genge in Canada will lead the randomized, double-blind placebo-controlled study. Stay tuned.
To learn more about masitinib and its potential as a treatment for ALS, check out The Phase III Results for Masitinib Are Now In. But Experts Remain Divided. To read the EMA’s Committee for Human Medicinal Products (CHMP) decision, check out their website here.
Trias E, Ibarburu S, Barreto-Núñez R, Babdor J, Maciel TT, Guillo M, Gros L, Dubreuil P, Díaz-Amarilla P, Cassina P, Martínez-Palma L, Moura IC, Beckman JS, Hermine O, Barbeito L. Post-paralysis tyrosine kinase inhibition with masitinib abrogates neuroinflammation and slows disease progression in inherited amyotrophic lateral sclerosis. J Neuroinflammation. 2016 Jul 11;13(1):177. [PubMed].
Martínez-Muriana A, Mancuso R, Francos-Quijorna I, Olmos-Alonso A, Osta R, Perry VH, Navarro X, Gómez-Nicola D, López-Vales R. CSF1R blockade slows the progression of amyotrophic lateral sclerosis by reducing microgliosis and invasion of macrophages into peripheral nerves. Sci Rep. 2016 May 13;6:25663. [PubMed].