Amylyx Reports Positive Phase 3 LUCIDITY Trial Results for Avexitide

Amylyx Pharmaceuticals announced positive topline results from its Phase 3 LUCIDITY clinical trial for avexitide, an investigational treatment for post-bariatric hypoglycemia (PBH). The study successfully met its primary and all secondary endpoints, showing a statistically significant reduction in hypoglycemic events for patients treated with avexitide compared to placebo.

Key Details

• Primary Endpoint: The trial demonstrated a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events versus placebo (p=0.000003).
• Safety Profile: Avexitide was reported as generally well-tolerated, with no treatment-related serious adverse events. The most common adverse events were mild or moderate.
• Regulatory Path: The company expects to submit a New Drug Application (NDA) to the U.S. FDA by the end of 2026, with a potential commercial launch anticipated in 2027, if approved.