Xeris Pharmaceuticals (NASDAQ:XERS) reported positive additional results from its global Phase 3 trial of ready-to-use (RTU) liquid glucagon.
Glucagon is the standard of care for treating severe hypoglycemia in diabetes patients. As with other injectable drugs, formulations are limited by drug stability and solubility, and usually require refrigeration. Xeris’ RTU liquid glucagon is room-temperature stable.
In the Phase 3 trial, which was conducted in 132 adults with Type 1 diabetes, RTU liquid glucagon demonstrated comparable efficacy to an approved glucagon emergency kit for achieving plasma glucose concentration of 70 mg per deciliter (dl), or an increase in plasma glucose concentration of 20 mg/dl or higher within 30 minutes of administration.
“This is our fourth Phase 3 trial with Xeris’ RTU glucagon. It provides further support of the effectiveness and utility of our RTU glucagon candidate, demonstrating again that it provides an effective alternative to currently available options for severe hypoglycemia,” Paul Edick, Xeris’ chairman and CEO, said in a statement.
The U.S. FDA is currently reviewing Xeris’ NDA for RTU glucagon, with an expected decision date of September 10, 2019.