Amylyx Pharmaceuticals’ experimental drug reportedly reduced dangerous episodes of low blood sugar in patients who have undergone bariatric surgery, in a late-stage trial.
Currently, there are no approved treatments for a condition known as post-bariatric hypoglycemia, which causes extreme blood sugar lows for some patients who have had gastric bypass surgery, usually soon after food and can cause cognitive impairment, loss of consciousness or seizures.
The condition is typically managed through dietary changes, blood sugar monitoring and carbohydrate-blocking medications.
Amylyx reported that in a 16-week trial, involving 78 patients, a once daily injection of the drug reduced hypoglycemic episodes by 55% versus placebo.
Avexitide, which is designed to inhibit specific GLP-1 receptors in the pancreas, preventing excessive insulin release, was generally well tolerated in the trial. According to Amylyx, the most common adverse effects were relatively mild to moderate and included diarrhea and bruising.
Following the success of the phase 3 trial, Amylyx shares climbed by 45% during morning trading. If the increase persists, the move could add approximately $1.15bn to the company’s market capitalisation.
This spike in market value comes after a difficult period for Amylyx. In 2024, the company withdrew its flagship ALS treatment Relyvrio from the U.S. and Canadian markets after a late-stage trial failed to demonstrate the expected benefit – a decision which led to layoffs and a corporate restructuring.
Amylyx have said they have $250mn in cash and that it plans to move quickly toward submitting a U.S. application for avexitide by the end of this year. The company is targeting a potential commercial launch in 2027.
Industry analysts estimate that avexitide could eventually generate as much as $2.2bn in annual U.S. sales at peak.
Amylyx obtained the rights to avexitide from Eiger BioPharmaceuticals in 2024, paying $35.1mn for the experimental treatment as part of Eiger’s bankruptcy proceedings.
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