Eiger BioPharmaceuticals Announces Presentation of Positive Phase 2 Results of Avexitide in Congenital Hyperinsulinism at the American Diabetes Association Virtual 81st Scientific Session
PALO ALTO, Calif., June 28, 2021 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc, (Nasdaq: EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced an oral poster presentation of Phase 2 study results of Avexitide in congenital hyperinsulinism (HI) at the American Diabetes Association (ADA) 81st Scientific Session. Avexitide is a targeted, first-in-class, GLP-1 antagonist in development for the treatment of HI, an ultra-rare, life-threatening, pediatric disorder of persistent hypoglycemia that results in irreversible brain damage in up to 50% of children.
This Phase 2 study measured the effect of avexitide infusion on glucose requirements in 13 neonates and infants with HI. Patients were randomized to single ascending doses of avexitide or placebo by continuous IV infusion in a crossover study design. Primary endpoint was glucose infusion rate (GIR). Avexitide significantly reduced GIR when evaluated across dose levels (p=0.0087) with dose-dependent improvements observed. Avexitide 100, 200 and 1,000 pmol/kg/min ascending doses demonstrated 1.3 (15%), 2.9 (24%), and 4.3 (56%) mg/kg/min reductions in GIR relative to placebo, respectively, and entirely abolished the glucose requirement in 50% of patients at the top dose. Avexitide was well-tolerated in this study. Adverse events were typically mild in severity and transient, and there were no serious adverse events.
This study was led by Diva De León, MD, Professor of Pediatrics and Chief of the Division of Endocrinology and Diabetes at Children's Hospital of Philadelphia (CHOP).
"Avexitide infusion demonstrated significant reductions in glucose infusion requirements to maintain euglycemia or normal glucose levels in neonates and infants," said Colleen Craig, MD, Vice President of Metabolic Diseases at Eiger. "Avexitide represents a promising, targeted approach for the treatment of congenital hyperinsulinism, an urgent, unmet medical need with no approved therapy."
"We are focused on completing all registration enabling activities to advance avexitide in congenital hyperinsulinism this year including regulatory concurrence, manufacturing, and device development," said David Cory, President and CEO at Eiger. "Our goal is to be Phase 3 ready as early as 2022."
About Phase 2 Study NCT00835328
Avexitide is also in development for post-bariatric hypoglycemia (PBH). Four clinical studies have been completed in 54 patients with PBH. Eiger has received concurrence from FDA and EMA on a single Phase 3 study for patients with PBH. 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 is not approved or commercialized for any indication. More information on avexitide clinical trials may be found at www.clinicaltrials.gov.
About Congenital Hyperinsulinism (HI)
Eiger's lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, type III, well-tolerated interferon entering Phase 3.
Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approved product. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Note Regarding Forward-Looking Statements
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SOURCE Eiger BioPharmaceuticals, Inc.
Company Codes: NASDAQ-NMS:EIGR