Amylyx Pharmaceuticals Inc. announced early safety and tolerability data from its Phase 1 LUMINA trial of AMX0114, an investigational antisense oligonucleotide targeting calpain-2, in people with amyotrophic lateral sclerosis (ALS). The data from the first cohort (n=12) were presented at the 36th International Symposium on ALS/MND held December 5-7, 2025, in San Diego, California. According to the company, AMX0114 was generally well-tolerated, with no treatment-related serious adverse events reported. Based on these findings, enrollment for the second cohort is expected to begin in Canada later this month and in the U.S. in January. Amylyx plans to present biomarker data from the first cohort in the first half of 2026.
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