FDA Approves Phase 3 Study of Pridopidine for ALS Treatment
Prilenia Therapeutics B.V. and Ferrer have received clearance from the U.S. Food and Drug Administration (FDA) to commence a pivotal Phase 3 study of pridopidine in patients with rapidly progressive amyotrophic lateral sclerosis (ALS). The study, named PREVAiLS, will involve 500 participants and will be conducted across 60 ALS treatment centers globally, including in the U.S., Canada, and Europe. The trial aims to confirm the efficacy and safety of pridopidine, building on promising results from a previous Phase 2 trial. The study will include a 48-week double-blind placebo-controlled phase followed by a 48-week open-label extension. The primary endpoint is the change in ALSFRS-R score adjusted for mortality, with secondary endpoints including speech and respiratory function. Recruitment is expected to begin in early 2026. 
