16 November 2018 - - US-based specialty pharmaceutical company Xeris Pharmaceuticals, Inc. (NASDAQ: XERS) has presented additional data supporting the efficacy and functional utility of its investigational ready-to-use, room-temperature stable liquid glucagon pen during the 18th Annual Diabetes Technology Meeting in North Bethesda, MD, November 8-10, 2018, the company said.

The additional data supported the company's recent filing to the US Food and Drug Administration for regulatory approval.

The data from three posters provide a closer look at the ease of use and effectiveness of the Xeris investigational glucagon pen as an alternative to currently marketed rescue systems, which require complex, multi-step preparation and administration processes.

These data outline the glucagon pen's efficacy in prompt and complete resolution of hypoglycemia in both adults and children with diabetes, as well as simplicity to facilitate successful administration during these critical settings.

The Phase 3, randomized, controlled, single-blind, crossover clinical trial compared the Xeris glucagon pen to the currently available Glucagon Emergency Kit to treat severe hypoglycemia in 81 adults with type 1 diabetes. The study demonstrated that the Xeris glucagon pen is practical and efficient in resolving symptoms of hypoglycemia.
All participants achieved successful plasma glucose recovery. The average time to symptom relief was comparable for autonomic symptoms (9.9 min vs. 9.8 min), neuroglycopenic symptoms (10.3 min vs. 9.9 min), and average total symptoms (13.0 min vs. 11.9 min).

The glucagon pen more quickly resolved global hypoglycemia symptoms than the GEK (11.6 min vs. 13.1 min).

The overall incidence of all adverse events was comparable in both groups.

Multiple evaluations have been conducted to evaluate the preparation time of the Xeris glucagon pen in comparison to the currently available GEK in controlled settings.

The assessments consisted of a simulated-use human factors study with 16 first responders and caregivers of diabetic patients and a validation study among 75 adults and adolescent caregivers both experienced and new to these systems.

In addition, a comparison of study drug preparation time was conducted during the Phase 3 clinical trial of the glucagon pen vs. GEK among adults with type 1 diabetes.

These evaluations support the use of the glucagon pen as an alternative to currently available options and validate that it can be used correctly, safely and effectively by its intended users.

Xeris is a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use, room-temperature stable injectable and infusible drug formulations.

The company's proprietary XeriSol and XeriJect formulation technologies are being evaluated for the subcutaneous and intramuscular delivery of highly-concentrated, non-aqueous, ready-to-use formulations of peptides, small molecules, proteins, and antibodies using commercially available syringes, auto-injectors, multi-dose pens, and infusion pumps.

XeriSol and XeriJect have the potential to offer distinct advantages over existing formulations of marketed and development-stage products, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous infusion.

These attributes may lead to products that are easier to use by patients, caregivers, and health practitioners and reduce costs for payers and the healthcare system.