6 July 2018 - - Chicago, Illinois-based specialty pharmaceutical company Xeris has presented positive results from two of its phase 3 clinical studies on its investigational ready-to-use, room-temperature stable liquid glucagon rescue pen during oral and poster sessions at the American Diabetes Association's 78th Scientific Sessions, the company said.
The presented data were from the phase 3 study on the efficacy and safety of the Xeris ready-to-use glucagon rescue pen in treating severe hypoglycemia in adults and children with type 1 diabetes, as compared to the currently marketed Glucagon Emergency Kit.
All participants achieved statistically significant increases in plasma glucose levels within 30 minutes of administration, reaching an increase in mean plasma glucose levels ≥ 25 mg/dL from baseline.
An additional phase 3 cross-over study of the Xeris rescue pen among adults with type 1 diabetes also generated positive data. In that study, all participants treated with the Xeris rescue pen achieved plasma glucose of >70 mg/dL or ≥ 20 mg/dl increase within 30 minutes of injection.
Xeris is leveraging its novel non-aqueous formulation technology platforms to develop and commercialize ready-to-use, room-temperature stable injectable and infusible drug formulations. The company's proprietary XeriSol and XeriJect formulation technologies allow for the subcutaneous and intramuscular delivery of highly-concentrated, non-aqueous, ready-to-use formulations of peptides, proteins, antibodies, and small molecules using commercially available syringes, auto-injectors, multi-dose pens, and infusion pumps.