Eiger Announces Breakthrough Therapy Designation Granted by FDA for Avexitide for Treatment of Post-Bariatric Hypoglycemia (PBH)
- Category: Proteins and Peptides
- Published on Tuesday, 18 June 2019 11:55
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- Third Eiger Pipeline Program Granted Breakthrough Therapy Designation
PALO ALTO, CA, USA I June 17, 2019 I Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare and ultra-rare diseases, today announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for avexitide for the treatment of post-bariatric hypoglycemia (PBH). FDA Breakthrough Therapy Designation involves a fast track development and FDA review process with guidance designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases. PBH is a chronic condition occurring in post-bariatric surgical patients leading to dangerously low, postprandial blood glucose levels. Severe PBH episodes can result in altered mental status, loss of consciousness, seizures, and coma. Due to increasing morbid obesity, the number of bariatric surgeries are increasing, leading to an increased number of patients suffering from PBH. Avexitide is a targeted, first-in-class, GLP-1 antagonist in development for the treatment of PBH, a chronic, debilitating disorder for which there is no approved treatment.
"Our avexitide PBH clinical program has dosed 54 patients across four Phase 2 studies, involving both inpatient and outpatient treatment, with promising results for patients suffering from post-bariatric hypoglycemia," said David Cory, President and CEO of Eiger. "We look forward to continued collaboration with the FDA, now on three Breakthrough Therapy Designation programs including lonafarnib for hepatitis delta virus (HDV) infection, lonafarnib for Hutchinson-Gilford Progeria Syndrome (Progeria) and Progeroid Laminopathies, and avexitide for post-bariatric hypoglycemia (PBH)."
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 has been dosed in 54 patients across four Phase 2 studies in patients suffering from PBH. Avexitide is well-tolerated with the most common treatment emergent adverse events including mild to moderate injection site bruising, nausea, and headache. Avexitide has been granted Breakthrough Therapy Designation by the FDA, as well as Orphan Drug Designation in the U.S. by the FDA for the treatment of hyperinsulinemic hypoglycemia and Orphan Drug Designation by the EMA for the treatment of non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS). Both of these broad orphan designations include PBH. Avexitide has never been approved or commercialized for any indication. More information on avexitide clinical trials may be found at www.clinicaltrials.gov.
About Post-Bariatric Hypoglycemia (PBH)
Approximately 150,000-200,000 bariatric surgical procedures are performed each year in the United States, and another 100,000 are performed each year in Europe. The estimated prevalence of PBH is approximately 30,000 in the United States and approximately 25,000 in the European Union. As the number of bariatric surgeries to treat obesity and related comorbidities has increased, so too has the number of individuals who experience PBH, with symptoms typically developing one or more years following surgery. PBH can occur with a range of severity in post-bariatric surgical patients. Severe hypoglycemia can result in neuroglycopenic outcomes (altered mental status, loss of consciousness, seizures, coma). Recurrent episodes of severe hypoglycemia can be debilitating with a significant negative impact on quality of life. There is no approved treatment for PBH.
Eiger is a late-stage biopharmaceutical company focused on the development and commercialization of a pipeline of first-in-class, well-characterized drugs for serious rare and ultra-rare diseases for patients with high unmet medical needs and for which no approved therapies exist.
The Company's lead program is in Phase 3, developing lonafarnib, a first-in-class prenylation inhibitor for the treatment of Hepatitis Delta Virus (HDV) infection. The company is also advancing peginterferon lambda, a first-in-class interferon, toward a Phase 3 study for the treatment of HDV. Eiger is preparing an NDA and MAA for lonafarnib to treat Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies with plans to file in 2019. For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
SOURCE: Eiger Biopharmaceuticals