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post-bariatric hypoglycaemia

Post-bariatric hypoglycaemia study completes enrolment

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 postprandial hypoglycaemia.

Eiger BioPharmaceuticals has completed enrolment of the Phase 2 multiple-ascending dose (MAD) study evaluating subcutaneous (SC) exendin 9-39 in post-bariatric surgical patients who experience dangerously low, postprandial blood glucose levels (hypoglycaemia) known as post-bariatric hypoglycaemia (PBH). 

“We have previously demonstrated positive proof of concept results in two separate single dose studies at Stanford, using an intravenous infusion and also a subcutaneous injection, that exendin 9-39 can prevent Hypoglycaemia in post-bariatric surgical patients during an oral glucose tolerance test (OGTT),” said Dr Lisa Porter, Senior Vice President, Metabolic Diseases at Eiger.  “We are encouraged by previously presented interim results of the ongoing MAD study with SC exendin 9-39 dosing up to three days with desired activity and tolerability. Exendin 9-39 represents the first potential targeted therapy for patients suffering from PBH, a significant unmet medical need.”

The MAD study is a dose-ranging trial designed to examine efficacy, safety, and PK of multiple-ascending doses of SC exendin 9-39 after up to three days of BID treatment to prevent hypoglycaemia and the accompanying symptoms. Twenty patients suffering from PBH were administered a baseline OGTT followed by administration of SC exendin 9-39 in a range of doses for up to three days. Interim results for 11 of 20 patients who completed up to three days of dosing were recently reported.

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 postprandial hypoglycaemia. Exendin 9-39 is being investigated as a novel treatment for PBH and has been granted orphan designation in the European Union by the EMA for the treatment of non-insulinoma pancreatogenous hypoglycaemia syndrome (NIPHS) and orphan designation in the US by the FDA for the treatment of hyperinsulinemic Hypoglycaemia.  Both of these broad designations include PBH. 

A therapy that safely and effectively mitigates insulin-induced Hypoglycaemia has the potential to address a significant unmet therapeutic need for certain rare medical conditions associated with hyperinsulinism.  Exendin 9-39 has never been approved or commercialized for any indication.  The long-term efficacy and safety of SC exendin 9-39 have not yet been established. 

Approximately 150,000-200,000 bariatric surgical procedures are performed each year in the United States, and another 100,000 are performed each year in Europe. The estimated prevalence of PBH is approximately 30,000 in the US and approximately 25,000 in the European Union.  As the number of bariatric surgeries to treat obesity and related comorbidities has increased, so too has the number of individuals who experience PBH, with symptoms typically developing 12 to 18 months following surgery.

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