Avexitide has been studied in a Phase 1 study in patients with bariatric surgery induced hyperinsulinemic hypoglycemia. This double-blinded, randomized placebo-controlled study evaluated the efficacy of a single IV infusion of avexitide in subjects with hyperinsulinemic hypoglycemia after an oral glucose challenge.
Subjects for this study suffered from hypoglycemia due to high levels of insulin secretion resulting in plasma glucose levels 50 mg/dL or lower 1-2 hours after meals.
Eight patients were given an oral glucose challenge and randomized to a 3.5 hour avexitide infusion or placebo in cross-over design. Endpoints included hypoglycemia and associated symptoms.
Mean data of 8 patients from the Phase 1 infusion study is shown in the figure below. All eight patients treated with avexitide mirrored glucose levels of healthy patients, with none of their glucose levels falling below 50 mg/dL. In contrast, all eight placebo patients had a steep glucose fall, with glucose levels falling below 50 mg/dL, and patients had to be rescued with IV dextrose. In this single-dose study, avexitide was tolerated with no observed side-effects.
Results published in Diabetologia 2016.
For more information, please visit www.clinicaltrials.gov NCT02550145
Eiger Bio has completed a single-ascending dose, subcutaneous administration of avexitide in 8 patients to explore the pharmacokinetic and pharmacodynamic profile of subcutaneously injected avexitide. Data was presented at the American Diabetes Association in June 2016.
See clinicaltrials.gov NCT02996812.
Eiger Bio has completed a multiple-ascending dose, subcutaneous administration of avexitide in 20 patients to export the pharmacokinetic profile of subcutaneously injected avexitide. Data was presented at the American Diabetes Association in June 2017.
See clinicaltrials.gov NCT02771574.
Eiger BioPharmaceuticals has initiated a Phase 2, 28-day study of subcutaneous administration of a proprietary novel liquid formulation of avexitide in up to 20 patients.
See clinicaltrials.gov NCT03373435
A Phase 2, Multicenter, Randomized, SinglE-Blind, Placebo-Controlled, Cross-oVer Study to Assess the Efficacy and Safety of ExeNdin 9-39 in PaTients with Postbariatric Hypoglycemia (PREVENT)