Phase III trial of Gvoke HypoPen showed efficacy in type 1 diabetes

Xeris Pharmaceuticals announced positive findings from a global Phase III trial of the Gvoke HypoPen, its ready-to-use (RTU) room-temperature stable liquid glucagon, conducted in Europe and North America. The Phase III, 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 a plasma glucose of more than 70 mg/dl or at least 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. A New Drug Application (NDA) for the investigational product, to be branded as the Gvoke HypoPen in the US, is currently under review with the U.S. Food and Drug Administration (FDA), with a decision expected September 10, 2019.

Comment: 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.