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Hypoglycaemia study

Post-gastric hypoglycaemia study treats first patient

Novel first-in-class GLP-1 antagonist targeted for rare hypoglycaemic condition

The first patient has been dosed in a Phase 2 study to evaluate subcutaneously administered exendin (9-39) in patients who experience dangerously low blood glucose levels (hypoglycaemia) after undergoing gastric bypass surgery. Exendin (9-39) is a 31-amino acid peptide, which selectively targets and blocks glucagon like peptide-1 (GLP-1) receptors, normalising insulin secretion by the pancreas, and thereby reducing hypoglycaemia.

The Exendin (9-39) 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 sixteen patients with documented hypoglycaemia after gastric bypass surgery. The study will assess control of hypoglycaemia 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. In addition, serial blood samples will be collected for pharmacokinetic and pharmacodynamic assessments. Various markers of drug activity will be assessed, including changes in glucose, insulin, C-peptide, and glucagon.

Stanford researchers have previously demonstrated in proof-of-concept exploratory clinical studies with exendin (9-39) that pharmacologic blockade of GLP-1 prevents hypoglycaemia in post-bariatric surgical patients and may represent the first targeted medical treatment for patients with post-gastric bypass hypoglycaemia.

Eiger BioPharmaceuticals acquired an exclusive license to a targeted therapeutic for treating post-bariatric surgical hypoglycaemia in November 2015. The technology was invented by Dr Tracey McLaughlin, Associate Professor of Medicine at Stanford University Medical Center in the Division of Endocrinology. There is currently no approved treatment for this condition, and severe cases have been surgically managed with near-total to total pancreatectomy, which results in insulin-dependent diabetes and is associated with up to a 6% surgical mortality risk.

"Increasing numbers of obese patients are turning to gastric bypass surgery as an effective means to rapidly and sustainably reduce weight and as a critical healthcare intervention," said David Cory, President and CEO of Eiger. "Unfortunately, some of these bypass surgery patients develop a chronic condition leading to severe hypoglycaemia after meals which cannot be managed by dietary modification or resolved by existing pharmacologic agents. A significant unmet medical need exists and there is no approved therapy."

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