Eiger BioPharmaceuticals has revealed it will focus its development efforts on advancing avexitide in hyperinsulinemic hypoglycaemia indications, following the company’s extensive portfolio prioritisation review.
Avexitide is an investigational, first-in-class glucagon-like peptide-1 receptor (GLP-1r) antagonist in development for the treatment of congenital hyperinsulinism and post-bariatric hypoglycaemia. By binding to the GLP-1r on pancreatic beta cells and preventing GLP-1r signalling, avexitide works upstream of beta cell insulin secretion to reduce dysregulated insulin secretion and the occurrence of hypoglycaemia. By addressing underlying disease mechanisms, avexitide may offer a targeted approach to treating hypoglycaemia in patients with hyperinsulinemic hypoglycaemia, including congenital hyperinsulinism and post-bariatric hypoglycaemia. Avexitide has been granted Breakthrough Therapy designation for both conditions.
"Today's environment necessitates prudent and strategic evaluation of how to advance our promising and diverse pipeline in order to develop potential breakthrough medicines for patients and to drive stockholder value," said Dr David Apelian, CEO of Eiger. "After a thorough examination of our programmes, we are deploying our resources toward recognizing the compelling potential of avexitide in metabolic diseases. Our initial focus will be on post-bariatric hypoglycaemia where we see the highest revenue potential, have demonstrated proof-of-concept in Phase 2 clinical trials, and have FDA alignment on Phase 3 endpoints, sample size and study design."
Post-bariatric hypoglycaemia and other forms of hyperinsulinemic hypoglycaemia after gastrointestinal surgeries are characterised by exaggerated secretion of glucagon-like peptide-1 (GLP-1) after meals, dysregulated secretion of insulin and a rapid drop in blood sugar.
Hypoglycaemia typically occurs one to three hours after meals and is often accompanied by symptoms of brain glucose starvation (neuroglycopenia), such as blurred vision, confusion, speech difficulty and incoordination.
“In the future, we also intend to develop avexitide for congenital hyperinsulinism as a second indication,” added Apelian. “We plan to provide further guidance next quarter on the progress of our business development efforts for our virology assets, as well as definitive plans for the PBH Phase 3 study initiation and key study milestones.”