US pharma company Xeris Pharmaceuticals announced that it has started dosing in a phase 2 trial with its ready-to-use, room temperature stable liquid glucagon in Type 1 diabetes patients who face episodes of exercise-induced hypoglycemia (EIH).
Xeris Pharmaceuticals is a specialty pharma company based in Chicago that utilizes its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations.
Its phase 2 clinical trial will assess ready-to-use glucagon as a pre-treatment for the prevention of exercise-induced hypoglycemia in 48 Type 1 diabetes patients. The enrolled patients will be subjected to daily insulin treatment through a subcutaneous infusion pump.
Patients will be given ready-to-use glucagon or placebo before at least 45 minutes of moderate or high-intensity aerobic exercise in a clinical research center in the two-period cross-over comparison study.
Further data will then be collected through a parallel comparison in an outpatient setting with a similar regimen that will see more than 30 minutes of aerobic exercise carried out by patients 3-5 times per week for a duration of 12 weeks.
Xeris Pharmaceuticals expects top-line results from the phase 2 clinical trial in H2 2019.
Dr. Ronnie Aronson, principal investigator on the EIH trial, said: “Many individuals with diabetes treated with insulin experience EIH and the complexity of managing it is a major barrier to the adoption of regular physical activity. And unfortunately, today there are no approved therapies to prevent EIH. This research will help us understand the potential for ready-to-use glucagon to offer real-world benefit in reducing or preventing these challenging events during exercise.”