Eiger BioPharmaceuticals Announces Completion of Enrollment in Phase 2 PREVENT Study of Avexitide (formerly Exendin 9-39) in Patients Suffering from Post-Bariatric Hypoglycemia
At Eiger's request, avexitide has recently been adopted by the
Avexitide is a first in class, GLP-1 antagonist in development as a convenient, novel liquid formulation for SC administration for PBH. Eiger has previously announced positive results from 3 separate proof of concept clinical studies involving 36 PBH patients treated with avexitide. Pharmacologic blockade of GLP-1 with avexitide has been shown to prevent hypoglycemia in post-bariatric surgical patients.
"Our previous clinical studies dosed PBH patients with avexitide for up to 3 days and demonstrated positive early proof of concept in the prevention of post-bariatric hypoglycemia during an oral glucose tolerance test (OGTT)," said
About the PREVENT Study
The PREVENT study is a Phase 2, multicenter, randomized, single-blind, placebo-controlled cross-over study to assess the efficacy and safety of 28-day dosing of avexitide in patients with post-bariatric hypoglycemia. Participants were randomized and assigned in a 1:1 ratio to one of two treatment arms. All participants received 2 dosing regimens of avexitide and matching placebo, self-administered via subcutaneous (SC) injection in an out-patient setting. Participants underwent in-clinic mixed meal tolerance test (MMTT) provocations with concomitant blood draws and symptom assessments. Outcomes include improvement in plasma glucose nadir levels and patient reported symptom scores.
About Insulin, GLP-1, and Avexitide
Insulin is the principal physiologic hormone secreted to control high blood glucose levels. Abnormal increases in insulin secretion can lead to profound hypoglycemia (low blood sugar), a state that can result in significant morbidities, including seizures, brain damage, and coma. GLP-1 is a gastrointestinal hormone that is released postprandially from the intestinal L-cells. GLP-1 binds to GLP-1 receptors on the beta cells of the pancreas and increases the release of insulin. In patients with PBH, GLP-1-mediated insulin secretion is dysfunctionally exaggerated.
Avexitide (formerly 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 hypoglycemia. Avexitide is being investigated as a novel treatment for PBH. Avexitide has been granted orphan designation in the
About Post-Bariatric Hypoglycemia (PBH)
Approximately 150,000-200,000 bariatric surgical procedures are performed each year in
About Eiger
Eiger is a clinical-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for rare diseases. We innovate by developing well characterized drugs acting on newly identified or novel targets in rare diseases. Our mission is to systematically reduce the time and cost of the drug development process to more rapidly deliver important medicines to patients with rare diseases. Our lead program in Hepatitis Delta Virus (HDV) infection, is moving into Phase 3 with a single, pivotal trial planned to initiate by the end of the year. For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
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This press release contains "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, business strategy and plans and objectives for future operations, are forward looking statements. These forward-looking statements include terminology such as "believe," "will," "may," "estimate," "continue," "anticipate," "contemplate," "intend," "target," "project," "should," "plan," "expect," "predict," "could," "potentially" or the negative of these terms. Forward looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned clinical development, including whether the D-LIVR study will be supported by the
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