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
Xeris 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 in-clinic stage of a Phase 2 study of its developmental ready-to-use (RTU) glucagon in patients who experience postprandial hypoglycemic episodes following bariatric surgery.
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.