Amylyx Pharmaceuticals said its Phase 3 Lucidity trial of avexitide in post-bariatric hypoglycemia hit its main goal, cutting the composite rate of level 2 and level 3 hypoglycemic events by 55% versus placebo through week 16, with a highly significant p-value of 0.000003.
The 78-patient study also met every secondary endpoint. Amylyx said avexitide reduced: level 2 events measured by self-monitoring of blood glucose level 2 events measured by continuous glucose monitoring * level 3 hypoglycemic events
The company said the trial was run at 21 U.S. sites and randomized participants 3:2 to 90 mg avexitide once daily or placebo.
Safety results were also clean in the double-blind period. Amylyx said there were no serious adverse events related to avexitide, the most common side effects were diarrhea, injection-site erythema, and injection-site bruising, and there were no changes in body weight in either group over 16 weeks.
Amylyx said it plans to file a new drug application with the FDA by year-end. The company is also targeting a potential commercial launch in 2027 if approved. Today the company's shares have moved 44.33% to a price of $30.93. For the full picture, make sure to review Amylyx Pharmaceuticals's 8-K report.
