What does the drug do?
Masitinib inactivates a cellular enzyme called tyrosine kinase, which is believed to be involved in tissue inflammation. While inflammation of the central nervous system may not be a direct cause of MND, it is likely to play a role in the speed of disease progression. Reducing the activity of inflammatory cells in the brain may reduce the damage to motor neurones.
The Phase 2/3 trial of this clinical trial examined the safety and effectiveness of masitinib in combination with riluzole in 394 people with MND, when taken for nearly a year. AB Science, the company behind masitinib, has published potentially promising results, showing improved ALSFRS-R score when given 4.5mg/kg of masitinib per day. However, no benefit on overall survival was observed. You can read more about the trial here.
The Phase 3 trial is a randomised, double blind, placebo controlled trial. It is looking to investigate the efficacy, measured by ALSFRS-R, of masitinib in combination of riluzole. Participants will be given two doses (4.5 and 6mg/kg/day) in combination with riluzole. You can read more here.
This trial is recruiting in the US and Germany only.
May 2022 - AB Science confirmed that Health Canada is now reviewing the new drug submission application for Masitinib. You can read more here.
Feb 2022 - AB Science confirmed that Health Canada granted authorisation to file a new drug submission for Masitinib. You can read more here.
Sept 2021 - AB Science confirmed that the study was allowed to resume, with some enhanced measures in place to ensure participant safety. You can read more here.
June 2021 - AB Science filed for a temporary hold on all ongoing studies until concluding an investigation of a potential risk of ischemic heart disease associated with masitinib use. You can read more here.