Amylyx Announces Positive Phase 3 Trial Results for Avexitide in Hypoglycemia

Amylyx Pharmaceuticals announced positive topline results from its Phase 3 LUCIDITY clinical trial for avexitide, an investigational treatment for post-bariatric hypoglycemia (PBH). The trial successfully met its primary endpoint, demonstrating a statistically significant reduction in hypoglycemic events. Following these results, the company plans to submit a New Drug Application (NDA) to the FDA.

Key Details

• Primary Endpoint: The trial met its primary endpoint, demonstrating a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo (p=0.000003).
• Regulatory Timeline: The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the end of 2026.
• Drug Profile: Avexitide, an investigational GLP-1 receptor antagonist, was generally well-tolerated in the 78-participant trial and has previously received Breakthrough Therapy Designation from the FDA for this indication.