Xeris’ G-Pen Mini (glucagon injection), a room-temperature stable glucagon product, is intended to be an effective and convenient treatment for mild-to-moderate hypoglycemia or low blood sugar.
Currently, glucagon is only approved for use in the glucagon emergency kits (GEKs) marketed by Eli Lilly and Company and Novo Nordisk for the treatment of severe hypoglycemia.
However, with these products, glucagon is available only as a dry powder in a sealed vial that must be reconstituted using a water-filled syringe in a multi-step process prior to injection. Xeris’ glucagon formulation is a stable, ready-to-inject liquid that can be packaged and delivered with a variety of devices including auto-injectors, pumps, and multi-dose pens (the latter in the form of the G-Pen Mini(TM) (glucagon injection) being the focus of this study).
"We are pleased to announce the start of this Phase 2 clinical study under the direction of Principal Investigator, Morey Haymond, MD at the Baylor College of Medicine in Houston, Texas" said Douglas R. Baum, Xeris’ CEO. "Our G-Pen Mini (glucagon injection) is the third Xeris glucagon product to begin Phase 2 testing. We successfully completed a Phase 2 trial with our first glucagon product, the G-Pen(TM) (glucagon injection) for treatment of severe hypoglycemia, and recently announced the initiation of our pumpable glucagon program. We plan to investigate the use of our soluble glucagon in a number of new applications in diabetes and in other conditions where hypoglycemia is prevalent."
"Our team is excited to partner with Xeris and utilize mini dosing of their stable glucagon to treat mild to moderate hypoglycemia," said Dr. Morey Haymond at Baylor College of Medicine.
"Having established the concept and the utility of mini dosing glucagon, the use of Xeris’ non-aqueous mini-dose glucagon has many advantages. It does not require mixing, uses subcutaneous injection, and is thus ready to use, making it far more convenient and acceptable for patients treating mild to moderate hypoglycemia. In many cases it is difficult or problematic for diabetic patients to consume carbohydrate-based calories when their blood glucose is low or dropping to dangerous levels. Therefore an additional advantage of glucagon mini-dosing is potentially avoiding more severe hypoglycemic events," he continued.
This Phase 2 clinical study is a single center, blinded, randomized, 3-way crossover dose ranging study in adult patients with type 1 diabetes. The study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics (efficacy) of Xeris’ G-Pen Mini(TM) (glucagon injection) for the treatment of mild-to-moderate hypoglycemia as a result of insulin treatment.