Amylyx presents new analyses from Phase 2, Phase 2b trials of avexitide

Amylyx (AMLX) Pharmaceuticals announced the presentation of new exploratory analyses from the Phase 2 PREVENT and Phase 2b clinical trials of avexitide, an investigational, first-in-class glucagon-like peptide-1, GLP-1, receptor antagonist for the treatment of post-bariatric hypoglycemia, PBH, at the Endocrine Society’s annual meeting, ENDO 2025. In the Phase 2b trial, avexitide 90 mg once daily, the dose being evaluated in the pivotal Phase 3 LUCIDITY trial, led to a 64% least-squares mean reduction vs. baseline in the composite rate of Level 2 and Level 3 hypoglycemic events in PBH, with more than half of the participants experiencing no events during the treatment period. The FDA-agreed-upon primary endpoint of LUCIDITY is reduction in the composite of Level 2 and Level 3 hypoglycemic events. Consistent reductions in composite rate of Level 2 and Level 3 hypoglycemic events also were seen with avexitide 45 mg twice daily studied in the Phase 2b trial and avexitide 30 mg twice daily and 60 mg once daily studied in the Phase 2 PREVENT trial. New pharmacokinetic and pharmacodynamic data were also presented demonstrating continuous pharmacologic activity of the 90 mg once daily dose regimen for a 24-hour period.