Signal Amylyx reports positive Phase 3 LUCIDITY topline results for avexitide in post-bariatric hypoglycemia

Summary

Amylyx Pharmaceuticals reported topline results from LUCIDITY, a 78-participant multicenter, randomized, double-blind, placebo-controlled Phase 3 trial of avexitide in post-bariatric hypoglycemia following Roux-en-Y gastric bypass. Avexitide is described as a first-in-class GLP-1 receptor antagonist. The trial met its FDA-agreed primary endpoint, showing a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events versus placebo (p=0.000003). All secondary endpoints were met, covering Level 2 events by self-monitoring of blood glucose, Level 2 events by continuous glucose monitoring, and Level 3 events. The most common adverse events were diarrhea, injection site erythema and injection site bruising, and no body weight changes were observed in either arm over the 16-week double-blind period. Avexitide holds Breakthrough Therapy and Orphan Drug designations, and the company plans to submit an NDA by year-end.