Amylyx completes enrollment in global Phase 3 trial of AMX0035 in ALS

Amylyx Pharmaceuticals announced the completion of enrollment in PHOENIX, a global, 48-week, randomized, placebo-controlled Phase 3 clinical trial of AMX0035 in people living with amyotrophic lateral sclerosis ALS . Amylyx anticipates topline results in 2024. The study enrolled 664 participants living with ALS. "The Phase 3 PHOENIX trial was an excellent collaboration between European and United States Centers for excellence in ALS research and care. We anticipate that PHOENIX will help us generate further data about the safety and efficacy of AMX0035," said Leonard H. van den Berg, MD, PhD, Professor of Neurology at UMC Utrecht in the Netherlands and Chairman of the Treatment Research Initiative to Cure ALS . "We are pleased to share this milestone from the PHOENIX trial, a collaborative effort to advance our scientific understanding of ALS and build upon the positive data from our Phase 2 CENTAUR trial," added Sabrina Paganoni, MD, PhD, principal investigator of the CENTAUR study, investigator at the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, and member of the Executive Committee of the Northeast Amyotrophic Lateral Sclerosis Consortium . The primary efficacy outcome of PHOENIX will be a joint assessment of Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised total score progression over 48 weeks, adjusted for mortality. Safety and tolerability will be assessed over 48 weeks.