Ready to Use, Room Temp Stable Glucagon Effective in Phase 3 Hypoglycemia Trial

If approved, it would be the first room temperature stable liquid glucagon in an autoinjector formulation.

Xeris Pharmaceuticals, Inc. announced positive results from a phase 3 trial of its ready-to-use (RTU) room-temperature stable liquid glucagon.

The  multicenter, randomized, non-inferiority study compared the efficacy and safety of Xeris RTU glucagon autoinjector 1mg with Novo Nordisk’s GlucaGen HypoKit 1mg to treat severe hypoglycemic events in 132 adults with type 1 diabetes. Patients were randomized to receive Xeris RTU glucagon during a visit to a clinical research center (CRC) and Novo Glucagon during another visit; each daytime visit was preceded by an overnight stay in the CRC. In the morning of the inpatient visit, patients were brought into a state of severe hypoglycemia (<54mg/dL) through IV administration of regular insulin.

Results showed comparable efficacy between the groups in achieving a plasma glucose of >70mg/dL or ≥20mg/dL increase in plasma glucose concentration within 30 minutes of glucagon administration (primary endpoint). Additionally, the time to resolution of hypoglycemia symptoms, as well as time to resolution of the overall feeling of hypoglycemia, were comparable between Xeris RTU glucagon and the marketed emergency kit (secondary endpoint).

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“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,” said Thomas Pieber, MD, 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.

The New Drug Application (NDA) for Xeris RTU glucagon is currently under review with the Food and Drug Administration (FDA) with a decision expected September 10, 2019. The product will be branded as the Gvoke HypoPen in the US.

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