Xeris Pharmaceuticals Announces Positive Topline Results From the In-clinic Stage of the Phase 2 Study of Its Developmental Ready-to-use (RTU) Glucagon in Patients at Risk of Postprandial Hypoglycemia Following Bariatric Surgery
All subjects successfully self-administered a mini dose of RTU glucagon
Rebound hypoglycemia observed more frequently in the placebo arm and with oral glucose tablet use
Subcutaneous RTU glucagon is safe and well-tolerated
This is a Phase 2 prospective, randomized, placebo-controlled, double-blind study that comprises an in-clinic stage followed by a 12-week outpatient stage. Subjects are randomly assigned to receive RTU glucagon or placebo during two separate meal challenges in an in-clinic stage crossover design, and then enter a parallel design outpatient stage where they are assigned to an investigational product for 12 weeks. In this study, subjects self-administer a mini dose (300 µg) of RTU glucagon or placebo when they experience hypoglycemia symptoms (e.g., anxiety, nausea, sweating, tremors, palpitations), and blood glucose response is measured after the study drug is self-administered. In situations where hypoglycemia (blood glucose ≤ 70 mg/dl) is present at mini-dosing or continues after treatment, oral glucose tabs are used in addition to the study drug. The in-clinic stage is now complete, and this study is currently ongoing in the outpatient stage, where both subjects and investigators remain blinded. For more information, visit www.clinicaltrials.gov Identifier: NCT03770637
Results from the in-clinic stage of this Phase 2 study demonstrate that most subjects experienced postprandial hypoglycemia within 90-120 minutes after finishing the meal. Of patients with a successful meal challenge, all subjects were also able to self-administer a mini dose of study drug, as directed, during the setting of declining blood glucose. A mini dose of RTU glucagon was adequate to restore or maintain normal blood glucose levels within 15 minutes of administration. This effect was maintained at 30 minutes, and hyperglycemia was not observed. The incidence of a follow-on episode of hypoglycemia (rebound hypoglycemia) requiring oral glucose for rescue was less with RTU glucagon compared to placebo. Treatment emergent adverse events with a mini dose of RTU glucagon were comparable to placebo, including negligible injection site reactions. Mini doses of RTU glucagon appear safe and well tolerated, and no serious adverse events occurred.
“We are encouraged by the results of the in-clinic stage of our PBH study. The first half of this study is an important first step in demonstrating the utility of liquid, stable, ready-to-use glucagon in conditions beyond rescue for severe hypoglycemia and demonstrating safety and effectiveness in situations that require self-administration by the patient,” said
About Post-Bariatric Hypoglycemia (PBH)
Approximately 200,000 weight loss (bariatric) surgeries are performed annually in
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.
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