Amylyx Pharmaceuticals announced Tuesday that its experimental drug avexitide met the primary endpoint in a late‑stage trial aimed at treating post‑bariatric hypoglycemia, a condition that can cause seizures, loss of consciousness, and severe cognitive impairment after weight‑loss surgery.
Trial design and results
The double‑blind, placebo‑controlled study enrolled 78 patients who had undergone bariatric procedures and continued to experience dangerously low blood‑sugar episodes. Participants received a once‑daily injection of avexitide or a matching placebo for 16 weeks. Over the study period, the avexitide group saw a 55% reduction in low‑blood‑sugar events compared with the placebo group.
Analysts at H.C. Wainwright had previously projected a “plausible band” of a 35% to 50% reduction for an encouraging outcome. The trial’s 55% reduction therefore exceeded those expectations.
How avexitide works
Avexitide is a GLP‑1 receptor antagonist. By blocking GLP‑1 receptors on insulin‑producing pancreatic cells, the drug limits excess insulin secretion, helping to stabilize blood‑glucose levels after meals. The mechanism addresses the root cause of post‑bariatric hypoglycemia rather than merely managing symptoms.
Safety profile
The study reported that avexitide was well‑tolerated. The most common adverse events were mild to moderate, including diarrhea and bruising at the injection site. No significant changes in body weight were observed in either the avexitide or placebo groups during the treatment period.
Regulatory outlook and market potential
There are currently no FDA‑approved therapies for post‑bariatric hypoglycemia, and patients typically rely on dietary modifications, frequent blood‑sugar monitoring, and carbohydrate‑blocking medications. Amylyx plans to submit a New Drug Application to the U.S. Food and Drug Administration by the end of 2026, with a target commercial launch in 2027.
TD Cowen analysts have projected peak U.S. sales of roughly $1.5 billion for avexitide, reflecting the unmet need among the estimated 8% of bariatric surgery patients who develop the condition.
Company background
Amylyx acquired avexitide from Eiger BioPharmaceuticals in 2024 for $35.1 million during Eiger’s bankruptcy auction. The company has positioned the drug as a potential first‑in‑class therapy for a niche but serious post‑surgical complication.
While the trial results are promising, further data from larger, longer‑duration studies will be needed to confirm durability of effect and long‑term safety. Nonetheless, the findings represent a significant step forward for patients struggling with post‑bariatric hypoglycemia and for the broader field of metabolic‑disorder therapeutics.
Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.
