Amylyx Pharmaceuticals announced that its experimental drug avexitide reduced low blood sugar episodes by 55% in a Phase 3 trial of 78 patients with post-bariatric hypoglycemia. The once-daily injection exceeded analyst expectations and safety profiles showed it was well-tolerated. Amylyx plans to seek U.S. regulatory approval by late 2026, targeting a potential 2027 launch for a condition that currently has no approved treatments and affects 8% of U.S. weight-loss surgery patients.
Avexitide Phase 3 trial results
- ▪The 55% reduction in low blood sugar episodes achieved by avexitide exceeded the 35% to 50% reduction forecast by H.C. Wainwright analysts
- ▪In a 78-patient Phase 3 trial, Amylyx Pharmaceuticals' once-daily injection avexitide reduced low blood sugar episodes by 55% compared to placebo over 16 weeks
- ▪The 55% reduction in low blood sugar episodes achieved by avexitide exceeded the 35% improvement the Phase 3 trial was statistically powered to show
Post-bariatric hypoglycemia condition
- ▪Post-bariatric hypoglycemia can cause significant cognitive or physical impairment, loss of consciousness, or seizures
- ▪There are currently no approved treatments for post-bariatric hypoglycemia, forcing patients to manage the condition through dietary changes, blood sugar monitoring, and carbohydrate-blocking medications
- ▪Post-bariatric hypoglycemia is a condition marked by dangerously low blood sugar levels that affects approximately 8% of weight-loss surgery patients in the United States
GLP-1 receptor blocking mechanism
- ▪Avexitide stabilizes blood glucose levels by blocking GLP-1 receptors on insulin-producing cells in the pancreas to reduce excess insulin secretion
- ▪Avexitide is administered as a once-daily injection designed to target GLP-1 receptors on insulin-producing cells in the pancreas
Safety profile tolerability data
- ▪Avexitide was well-tolerated in the trial, with mild to moderate diarrhea and bruising at the injection site being the most common side effects
- ▪No changes in body weight were observed in either the avexitide or placebo groups over the 16-week treatment period
U.S. regulatory approval timeline
- ▪Following the trial results, shares of Amylyx Pharmaceuticals rose by over 30% in premarket trading on August 18, 2026
- ▪Amylyx Pharmaceuticals plans to submit avexitide for U.S. regulatory approval by the end of 2026, aiming for a potential commercial launch in 2027
Commercial sales projections
- ▪Amylyx Pharmaceuticals acquired avexitide from Eiger BioPharmaceuticals for $35.1 million in 2024 during Eiger's bankruptcy auction
- ▪TD Cowen analysts projected peak United States sales of $1.5 billion for Amylyx Pharmaceuticals' experimental drug avexitide
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