US-based biopharmaceutical firm Xeris Pharmaceuticals (Xeris) has started dosing first patient in a Phase II clinical trial of its G-Pen (glucagon injection), a stable liquid glucagon, in normal healthy volunteers.
A total of 24 healthy volunteers will be involved in the single-centre, randomised, double-blind, three-way crossover Phase II clinical study.
In the study, the company will assess the safety, tolerability, comparative pharmacokinetics and pharmacodynamics of G-Pen formulation relative to Glucagon (Glucagon for Injection (rDNA Origin)) marketed by Eli Lilly and Company.
The trial’s primary endpoints include several parameters to assess safety and tolerability, while the secondary endpoints evaluate the change in plasma glucagon concentrations (pharmacokinetics) and the change in blood glucose levels (pharmacodynamics) as compared to Lilly’s Glucagon.
Xeris CEO Steve Prestrelski said the Phase II trial has been started under the direction of Ralph DeFronzo principal investigator at the Texas Diabetes Institute and the University of Texas Health Science Center.
"This marks a significant step in the evolution of Xeris from a research and discovery drug company to a clinical-stage drug company," Prestrelski said.
According to Xeris, G-Pen can stay stable at room temperature and is a ‘ready to inject’ formulation of glucagon designed for the treatment of severe hypoglycaemia in people with diabetes.
Eli Lilly and Company and Novo Nordisk are marketing the currently approved glucagon emergency kits (GEKs) that have glucagon as a dry powder in a sealed vial, which must be reconstituted in a multi-step process with a water-filled syringe prior to injection.
However, Xeris’s glucagon formulation does not require reconstitution as it is pre-mixed, and can be administered in just two steps.
DeFronzo added: "A product combining a stable glucagon with a patient-friendly, auto-injector pen is a major advance in the treatment of severe hypoglycemic events."
Xeris has received the US Food and Drug Administration (FDA) approval for the investigational new drug (IND) application of G-Pen in September 2013.
Xeris believes that its proprietary formulation has the potential to provide the first soluble, stable glucagon for use by people with diabetes to manage both moderate and severe hypoglycaemia.
Glucagon is a metabolic hormone secreted by the pancreas, which increases blood glucose levels by causing the liver to quickly convert glycogen (the stored form of glucose) into glucose which is later released into the bloodstream.
Two major hormones in a glycemic control system include glucagon and insulin, which keeps blood glucose at the right level in healthy individuals.