Shares of Amylyx Pharmaceuticals (AMLX +63.84%) surged on Tuesday after the biotechnology company announced positive clinical trial results for its investigational glucagon-like peptide-1 (GLP-1) receptor antagonist, avexitide.
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An unmet medical need
Roughly 8% of the 160,000 people in the U.S. who have had the two most common types of bariatric (weight loss) surgeries -- sleeve gastrectomy and Roux-en-Y gastric bypass (RYGB) -- suffer from chronic hypoglycemia, or low blood sugar.
Post-bariatric hypoglycemia (PBH) can cause serious medical issues, including cognitive dysfunction, physical impairment, loss of consciousness, and seizures. Yet there are currently no FDA-approved therapies for PBH.
An exaggerated GLP-1 response after eating, which causes a rapid drop in blood glucose, is believed to be a primary driver of PBH.
NASDAQ: AMLX
Key Data Points
Encouraging results
Avexitide met its primary endpoint in a Phase 3 study in participants with PBH following RYGB surgery, demonstrating a 55% reduction in severe hypoglycemic events compared to placebo.
Importantly, avexitide was also generally well-tolerated, with no serious adverse events related to treatment.
"Today's results are a major milestone that demonstrate avexitide's potential to address a critical treatment gap for the PBH community and represent a meaningful step forward for people living with this condition," Amylyx chief medical officer Camille Bedrosian said.
Amylyx intends to file a New Drug Application (NDA) with the FDA by the end of the year.
