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Xeris Pharmaceuticals Announces Positive Results From the Outpatient Stage of a Phase 2 Study of Its Developmental Gvoke Ready-to-Use (RTU) Micro™ Glucagon in Adults at Risk of Hypoglycemia During and After Aerobic Exercise
Results show a pre-treatment with a micro dose (150 µg) of Gvoke RTU Micro significantly prevented Exercise-Induced Hypoglycemia (EIH) during prolonged,
About this update from Xeris Biopharma Holdings, Inc.
[{"type":"text","content":"\nResults show a pre-treatment with a micro dose (150 µg) of Gvoke RTU Micro significantly prevented Exercise-Induced Hypoglycemia (EIH) during prolonged, moderate-to-high intensity aerobic exercise in a real-world setting with or without adjustment to insulin\n\n\nStudy achieved all primary objectives\n\n\nA micro dose of Gvoke RTU Micro demonstrated an encouraging safety and tolerability profile\n\n CHICAGO--(BUSINESS WIRE)--\nXeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced positive topline results from the outpatient stage of a Phase 2 study of its developmental Gvoke RTU Micro™ for the prevention of hypoglycemia during and after moderate-to-high intensity aerobic exercise in adults with Type 1 diabetes mellitus (T1D) who use insulin pumps. The clinical data was presented at a late-breaking session at the American Diabetes Association being held as a virtual event on June 12-16, 2020.\n\n\nIn the outpatient stage of this study, subjects were randomly assigned to RTU Glucagon with 50% insulin pump reduction (RTU Glucagon + standard of care); placebo injection with 50% insulin pump reduction (standard of care); or RTU Glucagon without insulin pump reduction (Open Label RTU Glucagon). For persons with diabetes, standard of care for aerobic exercise includes 50% insulin pump reduction. Results show that pretreatment with 150 µg of RTU glucagon was adequate to maintain normal blood glucose levels during prolonged, moderate-to-intense aerobic exercise.\n\n\nDuring the 12-week outpatient stage, 45 subjects completed 795 aerobic exercise sessions. Over this time when individually compared to standard of care alone, the number of EIH episodes was significantly less with RTU Glucagon + standard of care (8.5±1.17 episodes versus 2.5±1.26 episodes, P=0.0016), and with Open Label RTU Glucagon ( 8.5±1.17 episodes versus 3.9±1.37 episodes, P=0.0165). RTU Glucagon + standard of care resulted in an approximately 70% lower rate of EIH when compared to standard of care alone (12±14.1% versus 41±21.5% respectively, P180 mg/dL (2.4-fold). RTU Glucagon did not appear to individually contribute to hyperglycemia. When hyperglycemia events did occur, the time duration and severi...