Xeris Pharmaceuticals Announces Positive Results from the In-Clinic Stage of a Phase 2 Study of Its Developmental Ready-To-Use (RTU) Glucagon in Patients at Risk of Hypoglycemia During and after Aerobic Exercise
Results show a mini dose (150 µg) of RTU glucagon prevents Exercise-Induced Hypoglycemia (EIH) during prolonged, moderate-to-high intensity aerobic exercise in a clinical research setting
Results from the in-clinic stage of the Phase 2 Exercise-Induced Hypoglycemia (EIH) study show that a mini dose of RTU glucagon was adequate to maintain normal blood glucose levels during prolonged, moderate-to-intense aerobic exercise. Episodes of hypoglycemia were observed both during and after the prescribed exercise session. Overall, there were more EIH episodes among subjects who received standard of care (placebo plus 50% insulin pump reduction) than subjects who received RTU glucagon plus 50% insulin pump reduction. The use of glucose tablets to treat hypoglycemia during and after exercise was less with RTU glucagon when compared to standard of care. Treatment-emergent adverse events with a mini dose of RTU glucagon were comparable to placebo, including negligible injection site reactions. In this phase of the study, mini doses of RTU glucagon were safe and well tolerated, and no serious adverse events occurred.
“For people with Type 1 diabetes, prolonged and vigorous aerobic
exercise can be dangerous if not planned out and executed carefully. The
current standard of care includes multiple preparation steps, such as
insulin pump reduction well before exercise, and eating high glucose
foods before, during, and after the exercise session. These steps can be
a barrier to exercise, and therefore, many people with diabetes do not
achieve 2 ½ hours of aerobic exercise per week as per ADA guidelines,”
said
This study is a randomized, placebo-controlled, double-blind, two-treatment, two-period, crossover comparison in a clinical research center setting, followed by a randomized, placebo-controlled, two-treatment double-blind with a parallel open label, 3-arm comparison in an outpatient setting to evaluate the preliminary efficacy and safety of RTU glucagon to prevent EIH in adults with T1D, who perform regular, moderate-to-high intensity aerobic exercise. The in-clinic stage is now unblinded and complete, while the blinded outpatient stage is currently ongoing. The results of the outpatient stage will be available in the first half of 2020. For more information, visit www.clinicaltrials.gov Identifier: NCT03841526.
About Exercise-Induced Hypoglycemia (EIH)
For persons with diabetes, especially with T1D, the lack of pancreatic β-cell function leads to the requirement for exogenous insulin (introduced into the body by injection or infusion). Circulating levels of insulin consequently cannot be regulated endogenously and depend on the quantity and timing of insulin taken by the individual before exercise. Thus, insulin levels are often higher than they would be in the absence of diabetes, which has the result of limiting glucose production by the liver while stimulating glucose uptake by muscle, adipose, and liver cells for storage. As a result, blood glucose levels often decrease dramatically during physical activity for individuals with T1D unless carbohydrates are consumed before, during, and after exercise. This condition of low blood glucose with physical activity is known as EIH.
About Glucagon
Glucagon is a metabolic hormone secreted by the pancreas that raises blood glucose levels by causing the liver to rapidly convert glycogen (the stored form of glucose) into glucose, which is then released into the bloodstream. Glucagon and insulin are two critical hormones in a glycemic control system that keep blood glucose at the right level in healthy individuals. In people with diabetes who are dependent on insulin, this control system is disrupted, and insulin must be injected to avoid high levels of blood glucose (hyperglycemia). The opposite effect, or low blood glucose (hypoglycemia), is also prevalent in this population due to dysregulated glucagon secretion. Severe hypoglycemia is a serious condition and can lead to seizures, coma, potential brain injury and, if untreated, death.
Glucagon is the standard of care for treating severe hypoglycemia.
According to the
Xeris (Nasdaq: XERS) is a specialty pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world. With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable and infusible therapies, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke™. Its proprietary XeriSol™ and XeriJect™ formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. With Xeris’ technology, new product formulations are designed to be easier to use by patients, caregivers, and health practitioners and help reduce costs for payers and the healthcare system.
Xeris is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on Twitter, LinkedIn or Instagram.
Forward-Looking Statements
Any statements in this press release about future expectations, plans
and prospects for
The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200106005951/en/
Source:
Xeris Investor Contact
Allison Wey
Senior Vice
President, Investor Relations and Corporate Communications
awey@xerispharma.com
312-736-1237