Post-bariatric hypoglycemia (PBH) is a complication of bariatric surgery thought to be related to excessive insulin secretion in response to a meal. PBH can begin to occur one to eight years after gastric bypass surgery. These severe hypoglycemic episodes are characterized by extremely low blood sugar levels that occur two to three hours after a meal.
“The risk of hypoglycemic events can persist well beyond the initial recovery from post-bariatric surgery. Our goal is to determine if our ready-to-use glucagon can provide the reassurance of an effective treatment to promptly address these events if and when they occur, to support the patient’s continued recovery,” said Paul R. Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals. “Just weeks after initiating a similar study in exercised-induced hypoglycemia, we’re continuing to fuel a diverse and growing pipeline to evaluate the potential for our ready-to-use glucagon to benefit patients who may experience hypoglycemic episodes in a range of settings.”
This Phase 2, randomized, placebo-controlled, double-blind study will evaluate the efficacy, safety and tolerability of the Xeris ready-to-use glucagon in treating symptomatic postprandial hypoglycemia among 12 patients with PBH initially during two in-patient clinical research center visits, and then ongoing as part of a 12-week outpatient phase. Efficacy will be measured during confirmed hypoglycemic episodes by plasma glucose recovery (blood glucose >70 mg/dL) at 15 minutes after dosing with ready-to-use glucagon or placebo.
Xeris expects top-line data from the in-patient portion of the study in the second half of 2019.
Source: Company Press Release