US-based biopharmaceutical firm Eiger has reported positive results from a single ascending dose study of subcutaneously administered exendin (9-39) in post-bariatric surgical patients with low, postprandial blood glucose levels (hypoglycemia), known as post-bariatric hypoglycemia (PBH).
Exendin (9-39) is a 31-amino acid peptide that targets, classifies and blocks GLP-1 receptors and results in the normalising of insulin secretion by the pancreas subsequently reducing hypoglycemia.
The study featured a single ascending dose (SAD) design and was intended to assess the pharmacokinetics, pharmacodynamics, and local tolerability of three escalating doses of subcutaneous exendin (9-39).
The principal investigator of the study was Stanford University School of Medicine associate professor of Medicine (Endocrinology) Tracey McLaughlin.
The study included eight patients afflicted with PBH who were administered with oral glucose tolerance tests (OGTT) with and without subcutaneous exendin (9-39).
All of the eight patients exhibited reduced hypoglycemic symptoms and prevention of hypoglycemia at all dose levels of subcutaneous exendin (9-39).
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Exendin demonstrated a tolerable profile with no adverse effects recorded during the study.
Eiger president and CEO David Cory said: "Stanford researchers have now demonstrated in two separate clinical proof-of-concept studies, first using an intravenous infusion of exendin (9-39) and now using a subcutaneous injection of exendin (9-39), that pharmacologic blockade of glucagon-like peptide-1 (GLP-1) receptors prevents hypoglycemia in post-bariatric surgical patients during OGTT.
"A significant unmet medical need exists and exendin (9-39) represents the first potential targeted therapy for patients suffering from PBH."
Exendin acts as a therapy that safely and effectively works against insulin-induced hypoglycemia and can address the unmet therapeutic need for medical conditions such as hyperinsulinism.