Rebound hypoglycemia observed in the placebo arm with oral glucose tablet use; No rebound hypoglycemia observed in the RTU glucagon treatment arm
CHICAGO--(BUSINESS WIRE)-- Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced positive findings from the outpatient stage of a Phase 2 proof-of-concept study of its developmental ready-to-use (RTU) glucagon in patients who experience postprandial hypoglycemic episodes following bariatric surgery.
This was a Phase 2 prospective, randomized, placebo-controlled, double-blind proof-of-concept study that included an in-clinic stage followed by a 12-week outpatient stage. Subjects were 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 were assigned to an investigational product for 12 weeks. In this study, subjects self-administered a mini dose (300 µg) of RTU glucagon or placebo when they experienced hypoglycemia symptoms (e.g., anxiety, nausea, sweating, tremors, palpitations), and blood glucose response was 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 were recommended in addition to the study drug. For more information, visit www.clinicaltrials.gov Identifier: NCT03770637
Results from the 12 subject, 12-week outpatient stage recorded more than 200 postprandial hypoglycemia episodes across both treatment arms. Subjects frequently experienced postprandial episodes within 90-120 minutes after finishing meals and were able to successfully self-administer RTU glucagon during these events. Similar to the in-clinic stage, the sole use of a 300 µg RTU glucagon was adequate to restore or maintain normal blood glucose levels within 15 minutes of administration and maintained up to 120 minutes. During episodes when blood sugar was >70mg/dL at drug dosing, RTU glucagon and placebo were comparable in maintaining blood sugar within normal levels, and RTU glucagon did not elicit hyperglycemia. During episodes when blood sugar was 6 months to 8 years after surgery and is an uncommon and rarely reported metabolic complication that can be severe and disabling for some patients. Hypoglycemia episodes from PBH occur 1-3 hours after meals (postprandial hypoglycemia), often at a frequency of >10 times per month. Persistent or unrecognized hypoglycemia from PBH can progress to severe hypoglycemia (blood glucose