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Post-op hypoglycaemia

Positive Exendin (9-39) results for post-op hypoglycaemia patients

Exendin (9-39) is a 31-amino acid peptide that selectively targets and blocks GLP-1 receptors, normalising insulin secretion by the pancreas, and thereby reducing hypoglycaemia.

Positive results of a study evaluating subcutaneously administered exendin (9-39) in post-bariatric surgical patients who experience dangerously low, postprandial blood glucose levels (hypoglycaemia) known as post-bariatric hypoglycaemia (PBH), have been presented by Stanford researchers at the American Diabetes Association 2016 annual meeting in New Orleans.

The study used a single ascending dose (SAD) design to examine the pharmacokinetics, pharmacodynamics, and local tolerability of three escalating doses of subcutaneous exendin (9-39), developed by Eiger BioPharmaceuticals. Exendin (9-39) is a 31-amino acid peptide that selectively targets and blocks GLP-1 receptors, normalizing insulin secretion by the pancreas, and thereby reducing hypoglycemia. Exendin (9-39) is being investigated as a novel treatment for PBH. A therapy that safely and effectively mitigates insulin-induced hypoglycemia has the potential to address a significant unmet therapeutic need for certain rare medical conditions associated with hyperinsulinism.

Eight subjects suffering from PBH were enrolled and administered oral glucose tolerance tests (OGTT) with and without subcutaneous exendin (9-39). Hypoglycaemia was defined as a plasma glucose level of 50 mg/dL or less during OGTT. Prevention of hypoglycaemia and reduction in hypoglycaemia symptoms was achieved in all eight subjects at all dose levels of subcutaneous exendin (9-39).

Conversely, without subcutaneous exendin (9-39), all eight subjects became hypoglycaemia and required rescue during baseline OGTT when plasma glucose reached 50 mg/dL. Exendin (9-39) was well tolerated and no adverse reactions were noted. The principal investigator was Dr Tracey McLaughlin, Associate Professor of Medicine (Endocrinology) at the Stanford University School of Medicine.

“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 hypoglycaemia in post-bariatric surgical patients during OGTT,” said David Cory, President and CEO of Eiger. “A significant unmet medical need exists and exendin (9-39) represents the first potential targeted therapy for patients suffering from PBH.”

Exendin (9-39) has never been approved or commercialised for any indication. The long-term efficacy and safety of exendin (9-39) has not been established yet.

Approximately 150,000-200,000 bariatric surgical procedures are performed each year in the US, and another 120,000 are performed each year in Europe. The estimated prevalence of PBH is less than 200,000 in the US and less than 5 in 10,000 in the European Union, within the population prevalence for Orphan Designation in the US and European Union, alone or as a subset of hyperinsulinemic hypoglycaemia disorders.

As the number of bariatric surgeries to treat severe obesity has increased, so too has the number of individuals who experience PBH with symptoms developing one to several years following surgery. PBH can occur with a range of severity in post-bariatric surgery patients. Mild to moderate hypoglycemia may be managed largely through dietary carbohydrate restriction, whereas severe hypoglycemia results in neuroglycopenic outcomes (altered mental status, loss of consciousness, seizures) that are unresponsive to diet modification. There is no approved pharmacologic therapy.

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