Xeris Pharmaceuticals, a company developing ready-to-use injectable and infusible drug formulations, announced positive findings from a global phase 3 trial of its ready-to-use (RTU), room-temperature stable liquid glucagon conducted in Europe and North America.
The Phase 3, multi-center, randomized controlled, non-inferiority study was conducted among 132 adults with Type 1 diabetes to evaluate the Xeris RTU glucagon auto-injector as a treatment for severe hypoglycemic events as compared with Novo Nordisk’s GlucaGen® HypoKit®.
The results demonstrated comparable efficacy between the two groups for achieving plasma glucose of >70 mg/dl or ≥20 mg/dl increase in plasma glucose concentration within 30 minutes of glucagon administration.
The study also found that time to resolution of hypoglycemia symptoms as well as time to resolution of the overall feeling of hypoglycemia was comparable between Xeris RTU glucagon and the marketed emergency kit.
Overall, no safety or tolerability concerns were noted.
“As the population with Type 1 diabetes continues to grow in Europe, we need to ensure that patients and caregivers are equipped with effective, rapid-onset and easily administered solutions during potentially severe episodes of hypoglycemia,” said Dr. Thomas Pieber, professor of medicine, chair of the division of endocrinology and diabetology at the Medical University of Graz in Austria, and lead investigator of the study.
“Based on the results of this study, the Xeris ready-to-use, stable liquid glucagon may be an effective alternative to current options to effectively control these events, giving confidence to patients and their caregivers that they can quickly intervene during emergency settings,” he added.
This is Xeris’ fourth phase 3 trial with Xeris’ ready-to-use glucagon.
“It provides further support of the effectiveness and utility of our ready-to-use glucagon candidate, demonstrating again that it provides an effective alternative to currently available options for severe hypoglycemia,” said Paul R. Edick, chairman, and chief executive officer of Xeris Pharmaceuticals.
“We are confident in the profile of this treatment based on the rich data we’ve collected over the course of multiple trials. We also have a number of ongoing clinical trials to evaluate our liquid stable glucagon in other important potential indications,” he added.
A New Drug Application (NDA) for the investigational product, to be branded as the Gvoke HypoPen™ in the U.S., is currently under review with the U.S. Food and Drug Administration (FDA), with a decision expected September 10, 2019.
Xeris Pharmaceuticals. (2019, June 17). Xeris Pharmaceuticals Announces Additional Positive Outcomes from a Global Phase 3 Clinical Trial of Its Investigational Ready-to-Use Glucagon. BusinessWire. Retrieved June 19, 2019 from https://www.businesswire.com/news/home/20190617005256/en