Amylyx avexitide trial meets primary endpoint for hypoglycemia
Amylyx Pharmaceuticals reported positive results from its Phase 3 LUCIDITY trial of avexitide in managing hypoglycemia in post-bariatric surgery patients. The trial demonstrated a significant 55% reduction in composite Level 2/3 hypoglycemic events compared to placebo. Over 90% of participants completed the 16-week treatment period, with avexitide proving generally well-tolerated.
No deaths or serious treatment-related adverse events were reported. The FDA has granted Breakthrough Therapy Designation for the drug, which is estimated to impact about 160,000 people in the U.S. who have undergone bariatric surgery. Amylyx plans to submit a New Drug Application by year-end, with a potential commercial launch in 2027 if approved.
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