Eiger Announces Publication of Phase 2 PREVENT Study Results of Avexitide in Post-Bariatric Hypoglycemia in Journal of Clinical Endocrinology & Metabolism
PREVENT is the first randomized placebo-controlled study to evaluate the efficacy of a pharmacologic agent for patients with PBH in the outpatient setting. PREVENT investigated the safety and efficacy of Avexitide administered as 30 mg twice daily (BID) or 60 mg once daily (QD) subcutaneous (SC) injections in post-bariatric surgical patients who experience chronic, dangerously low, postprandial blood glucose levels, known as post-bariatric hypoglycemia or PBH.
Patients with severe PBH experience frequent postprandial episodes of hypoglycemia accompanied by neuroglycopenic signs and symptoms, including altered mental status, visual changes, motor incoordination, loss of consciousness, and seizures, putting patients at risk for injury or death from falls, motor vehicle accidents, or prolonged hypoglycemia and rendering many unable to drive, work, live alone, or care for dependents. Avexitide is a targeted, first-in-class, GLP-1 antagonist in development for the treatment of hyperinsulinemic hypoglycemia conditions, including PBH and congenital hyperinsulinism (CHI), disorders for which there are no approved treatments.
Primary endpoint was met with statistical significance by both dosing regimens. During hypoglycemia provocation in the clinical setting, the mean plasma glucose nadir was increased by 21% (p=0.001) and 26% (p=0.0002) following Avexitide 30 mg and 60 mg dosing, respectively, compared to placebo, corresponding to 50% and 75% fewer participants requiring rescue. Consistent with Avexitide's mechanism of action, peak insulin was reduced by 23% (p=0.029) and 21% (p=0.042) following Avexitide 30 mg and 60 mg dosing, respectively.
Metabolic and clinical parameters were also monitored during each patient's daily routine in the outpatient setting as assessed by self-blood glucose monitoring (SBGM), electronic diary, and blinded continuous glucose monitoring (CGM). Patients experienced significantly fewer Levels 1-3 hypoglycemia events during Avexitide treatment, defined, respectively as SBGM <70 mg/dL, SMBG <54 mg/dL, and a severe event characterized by altered mental and/or physical functioning requiring assistance. Patients also demonstrated reductions in percent time in hypoglycemia during diurnal periods (
Avexitide was well-tolerated in this study. The most common adverse events were injection site bruising, nausea, and headache, all of which occurred with lower frequency during Avexitide vs. placebo treatment.
"Avexitide treatment demonstrated significant and consistent improvements across multiple clinical and metabolic parameters, as measured both in the clinical setting during hypoglycemia provocation and in the patient home setting under 'real world' conditions. Significant improvements in primary and secondary endpoints were observed, with reductions in postprandial hyperinsulinemic hypoglycemia during mixed meal provocation," said
Avexitide is a well-characterized, first-in-class, 31-amino acid GLP-1 antagonist that selectively targets and blocks GLP-1 receptors, normalizing insulin secretion by the pancreas, and thereby reducing postprandial hypoglycemia. Avexitide is Phase 3 ready and has received concurrence from FDA and EMA on a single Phase 3, registration-enabling study of Avexitide in severe PBH. Avexitide has been granted Breakthrough Therapy Designation by the FDA, as well as Orphan Drug Designation in the
Eighteen patients with refractory, severe PBH were enrolled across five
About Post-Bariatric Hypoglycemia (PBH)
Approximately 150,000-200,000 bariatric surgical procedures are performed each year in
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