Xeris Pharmaceuticals, Inc. — Department of Health and Human Services SBIR Phase I: NIDDK

Description

DESCRIPTION provided by applicant The objective of this Fast Track program is to develop a novel stable non aqueous glucagon formulation with an infusion pump system in closed loop with continuous glucose monitoring for treatment of post bariatric surgery patients who have experienced repetitive severe postprandial hypoglycemia This approach will provide a automated or semi automated glucagon b personalized dosing that will not trigger hyperglycemia and c provide a more economical treatment strategy In this patient population eating to correct hypoglycemia can actually trigger another subsequent hypoglycemic event whereas glucagon acts to increase blood glucose levels without triggering excess insulin secretion Thus there is an urgent need for improved approaches for the treatment of severe hypoglycemia to maintain health allow optimal nutrition and improve safety in patients with post bariatric hypoglycemia PBH syndrome The primary objective of the current proposal is directly relevant to the NIDDK research priorities for obesity treatment and prevention as well as type diabetes treatment The Phase I effort of this project will develop algorithms using CGM information to trigger real time alerts in the presence of hypoglycemia using an automated trigger algorithm that will deploy and deliver a dose of soluble glucagon from a pump and test this proof of concept POC in a clinical setting The Phase II effort of this program will take th optimized algorithm from Phase I into a closed loop pump system for use in a randomized blinded placebo controlled clinical trial The data generated in the project may also enable future outpatient studies in which patients can test the system in andquot real lifeandquot situations We propose that the resulting closed loop glucagon CLG system with Xerisandapos glucagon in an OmniPod r will be a more effective treatment for PBH syndrome PUBLIC HEALTH RELEVANCE The objective of this Fast Track program is to further the development of a novel stable non aqueous glucagon formulation with an infusion pump system in closed loop with continuous glucose monitoring for treatment of post bariatric surgery patients who are at high risk for postprandial hypoglycemia