Eiger BioPharmaceuticals has dosed its first patient in a Phase ll multiple ascending dose study to evaluate subcutaneously administered Exendin (9-39) in patients who experience dangerously low blood glucose levels (hypoglycemia) after undergoing gastric bypass surgery.
Exendin (9-39) is a 31-amino acid peptide, which selectively aims and blocks glucagon like peptide-1 (GLP-1) receptors, normalising insulin secretion by the pancreas, and thereby reducing hypoglycemia.
It is now being investigated as a new treatment for bariatric surgery-induced hypoglycaemia.
Researchers in Stanford University, US, have already demonstrated in proof-of-concept exploratory clinical studies with exendin (9-39) that pharmacologic blockade of GLP-1 prevents hypoglycemia in post-bariatric surgical patients, and may represent the first targeted medical treatment for patients with post-gastric bypass hypoglycemia.
Eiger noted that exendin (9-39) Phase ll study is a randomised, blinded, multiple ascending dose study designed to evaluate four different doses of subcutaneously administered exendin (9-39) during a three-day repeat dosing period in 16 patients with documented hypoglycemia after gastric bypass surgery.
Around 150,000 to 200,000 bariatric surgical procedures are currently performed each year in the US, and another 120,000 are performed each year in Europe.
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As the number of gastric bypass surgeries to treat severe obesity has increased, so too has the number of individuals who experience postprandial hypoglycemia or low blood glucose following a meal.
At present, there is no approved pharmacologic therapy for the disease.
The exendin (9-39) Phase ll multiple ascending dose study will assess control of hypoglycemia and associated symptoms during the three-day dosing period through metabolic testing pre and post-treatment.
Safety and tolerability will be monitored throughout the study.
Serial blood samples will be additionally collected for pharmacokinetic and pharmacodynamic assessments.
Various markers of drug activity will be evaluated, including changes in glucose, insulin, C-peptide, and glucagon.