Amylyx Pharmaceuticals has acquired avexitide, an investigational therapy for hyperinsulinemic hypoglycemia, from Eiger BioPharmaceuticals. Avexitide, a novel GLP-1 receptor antagonist, has potential applications in treating post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (HI).
Hyperinsulinemic hypoglycemia occurs when the body produces excessive insulin, leading to dangerously low blood sugar levels. PBH is a complication that can arise after bariatric surgery, while HI is a rare congenital condition.
The U.S. Food and Drug Administration (FDA) has granted avexitide Breakthrough Therapy Designation for PBH and congenital HI. It has also received an Orphan Drug Designation for treating hyperinsulinemic hypoglycemia.
Avexitide has shown promising results in clinical trials for PBH. In Phase 2 studies, it significantly reduced hypoglycemic events, including severe episodes requiring assistance. The FDA has indicated that a reduction in hypoglycemia events could support approval for the drug.
Amylyx plans to initiate a Phase 3 clinical trial for avexitide in PBH in the first quarter of 2025. The company also engages with the congenital HI community to explore the drug’s potential in treating this condition.
Amylyx’s acquisition of avexitide strengthens its focus on endocrine and neuroscience treatments and aligns with its mission of providing innovative therapies for unmet medical needs. Avexitide has the potential to address the debilitating effects of hyperinsulinemic hypoglycemia and improve the lives of affected individuals.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
