Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced the presentation of data from its first-in-human, dose-ranging Phase 1 LUMINA trial of AMX0114 at the European Network to Cure ALS (ENCALS) Meeting 2026, held from June 24-26, 2026 in Madrid, Spain.
AMX0114 showed no drug-related serious adverse events (SAEs) and no serious neurological adverse events (AEs) in Cohort 1 (lowest dose level 12.5 mg). These safety findings support continued evaluation of AMX0114 at higher dose levels in this multiple ascending dose trial. Biomarker levels, including spectrin breakdown product 145 (SBDP-145), neurofilament light (NfL), and phosphorylated neurofilament heavy (pNFH), remained near baseline. Cohort 1 evaluated the lowest dose level, and future cohorts will evaluate the impact of higher dosage levels.
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