Xeris Pharmaceutical Inc. (NASDAQ:XERS) has announced promising topline data form its outpatient stage of the second phase study of Gvoke Ready to Use (RTU) MicroTM in preventing hypoglycemia.
Xeris releases positive Gvoke RTU Micro study results in exercise-induced hypoglycemia
The study evaluates the Gvoke RTU Micro in preventing low glucose levels in Type 1 diabetes patients using insulin pumps during and after moderate to high power aerobic exercises. Study participants in this outpatient stage study were allocated randomly to RTU Glucagon with an insulin pump reduction of 50% as well as a placebo standard of care with an insulin pump reduction of 50%. Alternatively, some subjects were given the only glucagon in the open-label RTU glucagon without insulin pump reduction. For diabetes persons, the aerobic exercise standard of care included 50% insulin pump reductions.
According to results, 150 µg pretreatment with RTU glucagon maintained normal blood glucose levels in length moderate to high power exercise. In the 12-week study, 45 participants finished around 795 aerobic exercise sessions. During the time, comparison with standard care only showed that the numbers of EIH incidences were much less when RTU glucagon plus standard care was applied. Throughout the sessions, the use of glucose tablets when exercising and after managing hypoglycemia was high in the standard care arm relative to the RTU glucagon plus standard of care and open-label RTU Glucagon.
Micro doses of Gvoke RTU glucagon can prevent the risk of hypoglycemia
Ronnie Aronson, the principal investigator of the study, indicated that the study demonstrated that pretreatment with RTU micro glucagon doses minimizes the risk of exercise-related hypoglycemia. Therefore it has the potential of reducing anxiety and the problem of hypoglycemia when exercising.
Xeris CEO and Chairman Paul Edick indicated that the outpatient results demonstrated that 150 µg micro-dose of Gvoke RTU glucagon can alleviate the risk of hypoglycaemic during and after exercise. The CEO stated that the company was looking forward to ending the second phase of the FDA meeting this year and charting the program’s clinical pathway.