EigerBio Pharmaceuticals has dosed the first patient in its PREVENT study evaluating the efficacy and safety of exendin 9-39 in post-bariatric surgical patients who experience dangerously low postprandial blood glucose levels known as post-bariatric hypoglycemia (PBH).
The Phase II cross-over study will enrol 20 PBH patients across various sites in the US.
In the trial, subjects will be randomised and distributed in a 1:1 ratio to one of two treatment arms.
All participants will receive two dosing regimens of exendin 9-39 and matching placebo, self-administered via subcutaneous (SC) injection.
The trial will examine in-clinic mixed meal tolerance test (MMTT) provocations, as well as associated blood draws and symptom assessments of all the patients.
Eiger BioPharmaceuticals Metabolic Diseases senior vice-president Lisa Porter said: “The PREVENT study will test multiple doses and evaluate durability of effect of exendin 9-39 for longer treatment periods in patients suffering from PBH.
“Exendin 9-39 is the first potential targeted therapy for PBH, a significant unmet medical need.”
The company has been developing exendin 9-39 as a 31-amino acid peptide that selectively targets and blocks GLP-1 receptors to normalise insulin secretion by the pancreas, thereby reducing postprandial hypoglycemia.
The liquid formulation for SC administration for PBH has previously received orphan designation in the European Union by the European Medicines Agency (EMA) for the treatment of non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS).
It has also received orphan designation from the US Food and Drug Administration (FDA) for the treatment of hyperinsulinemic hypoglycemia.