Eiger BioPharmaceuticals has completed patient enrolment in the Phase ll Prevent trial evaluating the safety and durability of subcutaneous (SC) effect of avexitide (formerly exendin 9-39) for the treatment of patients with post-bariatric hypoglycemia (PBH).
PBH patients experience dangerously low, postprandial blood glucose levels (hypoglycemia), and currently there is no US Food and Drug Administration (FDA) approved pharmacologic therapy available for the disease.
The multi-centre, randomised, single-blind, placebo-controlled cross-over trial has enrolled a total of 18 patients across five study sites in the US.
The enrolled patients were already randomised and assigned in a 1:1 ratio to receive one of two treatment arms, including avexitide and placebo, for a period of 28 days.
The patients have received two dosing regimens of avexitide and matching placebo, self-administered via subcutaneous (SC) injection under an out-patient setting.
They also went through in-clinic mixed meal tolerance test (MMTT) provocations with concomitant blood draws and symptom assessments.
Objectives of the trial comprise improvement in plasma glucose nadir levels and patient-reported symptom scores.
Eiger BioPharmaceuticals Metabolic Diseases chief medical officer Lisa Porter said: “Our previous clinical studies dosed PBH patients with avexitide for up to three days and demonstrated positive early proof of concept in the prevention of post-bariatric hypoglycemia during an oral glucose tolerance test (OGTT).
“Prevent is our first out-patient study evaluating multiple doses and durability of effect of avexitide for a treatment period of 28 days in patients suffering from PBH.
“We look forward to reporting top line results of the Prevent study later this year.”
Avexitide is a glucagon-like peptide-1 (GLP-1) antagonist currently under development as a new liquid formulation for SC administration for PBH.