AB Science has recently received clearance to initiate the Phase 3 trial of masitinib for amyotrophic lateral sclerosis (ALS) treatment in the United States and select European countries. This trial, designated as AB23005, has been authorized by the U.S. FDA and validated by the European Medicines Agency. Spain, Greece, and Slovenia have already granted approval for the trial’s launch in Europe. The study aims to evaluate the safety and efficacy of masitinib compared to a placebo in over 400 ALS patients undergoing treatment with riluzole. Dr. Albert Ludolph, the principal investigator from the University of Ulm in Germany, expressed optimism about the trial’s potential based on robust clinical and preclinical data supporting masitinib’s mechanism of action in slowing ALS progression. Masitinib acts by inhibiting tyrosine kinases, enzymes crucial for immune cell function implicated in ALS-related inflammation and nerve cell damage. Previous Phase 2/3 trial results and preclinical studies have provided promising insights into masitinib’s therapeutic effects in ALS.
Read more from alsnewstoday.com