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AUSTIN, Texas, Oct. 17, 2013 (GLOBE NEWSWIRE) -- Xeris Pharmaceuticals, Inc. ("Xeris"), a clinical stage,specialty biopharmaceutical company developing novel non-aqueousformulations of injectable drugs, announced today the dosingof the first subject in a Phase 2 clinical study of thecompany's stable liquid glucagon in normal healthyvolunteers. Xeris' G-Pen™ (glucagon injection) has potentialas a room temperature stable, "ready to inject" glucagon for thetreatment of severe hypoglycemia in people with diabetes. Thecurrently approved glucagon emergency kits (GEKs) marketed byEli Lilly and Company and Novo Nordisk contain glucagon as a drypowder in a sealed vial, which must be reconstituted in amulti-step process with a water-filled syringe prior toinjection. Xeris' glucagon formulation does not requirereconstitution as it is pre-mixed, allowing for administration inonly two steps.
"We are very pleased to announce the initiation of this Phase 2clinical study under the direction of principal investigator, RalphDeFronzo, MD at the Texas Diabetes Institute and the University ofTexas Health Science Center in San Antonio, Texas," said StevePrestrelski, PhD, Xeris' CEO. "This marks a significant stepin the evolution of Xeris from a research and discovery drugcompany to a clinical-stage drug company."
"We are very excited to be collaborating with Xeris on thesoluble glucagon clinical trial here at the Texas DiabetesInstitute in San Antonio," said Dr. Ralph DeFronzo. "Aproduct combining a stable glucagon with a patient-friendly,auto-injector pen is a major advance in the treatment of severehypoglycemic events," he continued.
The Phase 2 clinical trial is a single-center, randomized,double-blind, three-way crossover trial in 24 healthyvolunteers. The study is designed to evaluate the safety,tolerability, and comparative pharmacokinetics and pharmacodynamicsof Xeris' G-Pen™ (glucagon injection) formulation relative toGlucagon (Glucagon for Injection (rDNA Origin)) marketed by EliLilly and Company. The primary endpoints include a variety ofparameters to assess safety and tolerability. The secondaryendpoints assess the change in plasma glucagon concentrations(pharmacokinetics) and the change in blood glucose levels(pharmacodynamics) as compared to Lilly's Glucagon. TheInvestigational New Drug (IND) application for the G-Pen™ (glucagoninjection) received FDA clearance on September 25, 2013.
Xeris wishes to acknowledge the financial support for theclinical trial from a Small Business Innovation Research (SBIR)grant (5R44DK085809-03) from the National Institute ofDiabetes Digestive and Kidney Diseases.
Glucagon is a metabolic hormone secreted by the pancreas thatraises blood glucose levels by causing the liver to rapidly convertglycogen (the stored form of glucose) into glucose which is thenreleased into the bloodstream. Glucagon and insulin are twocritical hormones in a glycemic control system that keeps bloodglucose at the right level in healthy individuals. In people withdiabetes who are dependent on insulin, this control system isdisrupted and insulin must be injected prior to meals to avoid highlevels of blood glucose (hyperglycemia). The opposite effectof low blood glucose (hypoglycemia) is also prevalent in thispopulation resulting from too much insulin followed by too small ameal without enough carbohydrates. Severe hypoglycemia is a seriouscondition and can lead to seizures, coma, potential brain injuryand, if untreated, death. Xeris proprietary formulation hasthe potential to provide the first soluble, stable glucagon for useby people with diabetes to manage both moderate and severehypoglycemia.
About Xeris Pharmaceuticals, Inc.
Xeris is an Austin, Texas-based biopharmaceutical companydeveloping improved injectable drugs for indications includingdiabetes and epilepsy. The company's proprietary non-aqueousformulation technologies allow for the subcutaneous andintradermal delivery of highly concentrated, non-aqueous paste andliquid formulations of small molecules, peptides, proteins,antibodies, and nucleic-acid-based therapeutics. Xeris'proprietary delivery system offers distinct advantages overexisting formulations and delivery approaches including: upto 1000-fold lower injection volume, no reconstitution, theelimination of refrigeration with room temperature shelf-lifestability, and the ease-of-use and reduce costs of simpleself-administration for millions of patients and caregivers. For more information please visit the Xeris websiteat: www.xerispharma.com
A file accompanying this release is available at:
Source:Xeris Pharmaceuticals, Inc.