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Reported Sunday, Amylyx Highlights Efficacy And 24-Hour Coverage Of Avexitide 90 mg Daily; Supports Advancing Phase 3 LUCIDITY Trial

Author: Benzinga Newsdesk | July 14, 2025 02:47am

Pivotal Phase 3 LUCIDITY trial of avexitide, a potential first-in-class GLP-1 receptor antagonist with FDA Breakthrough Therapy designation, underway in post-bariatric hypoglycemia; completion of recruitment expected in 2025, with topline data anticipated in first half of 2026
In the Phase 2b trial, avexitide 90 mg once daily led to a 64% least-squares mean reduction in the composite rate of Level 2 and Level 3 hypoglycemic events in post-bariatric hypoglycemia, the FDA-agreed upon primary outcome that LUCIDITY is evaluating
Population pharmacokinetic and pharmacodynamic data demonstrated avexitide 90 mg once daily has sustained therapeutic exposure for 24 hours

Posted In: AMLX