Xeris Pharmaceuticals, Inc., a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, announced today that Jessica Castle, M.D., an associate professor of medicine in the OHSU School of Medicine and OHSU Harold Schnitzer Diabetes Health Center in Portland, Oregon, is conducting a clinical trial with a dual-hormone artificial pancreas using Xeris' ready-to-use liquid glucagon to evaluate a new closed-loop algorithm.
Managing diabetes requires ongoing monitoring of blood glucose levels and regular intervention with glucose and insulin - a burdensome process for the over five million people on insulin in the United States. Automated insulin delivery (AID) systems available today can dial up and down or stop the delivery of insulin. They are limited in their ability to co-deliver glucagon, as current dry-powder glucagon formulations must be used immediately because they begin to degrade after reconstitution.
Xeris' ready-to-use liquid glucagon is room-temperature stable over extended periods of time, thereby enabling a dual-hormone artificial pancreas system to be possible. The ability to co-administer both insulin and stable liquid glucagon in one system may reduce the risk of hypoglycemia by mirroring the body's normal glucose control, which is especially important during periods of exercise.
Supported by funding from JDRF, the leading global organization funding type 1 diabetes (T1D) research, OHSU is conducting a Phase 1 single-center, randomized, three-way, controlled, crossover clinical study to test the efficacy of a new closed-loop algorithm for managing blood glucose in people with T1D before and after exercise.
"JDRF is excited to support OHSU's research into ready-to-use liquid glucagon," said Marlon Pragnell, Ph.D., JDRF associate director of research. "This program has the potential to change the way millions of active individuals with T1D monitor and treat their glucose levels."
The purpose of this study is to determine whether a dual hormone artificial pancreas using Xeris' ready-to-use liquid glucagon with an exercise detection algorithm outperforms both single hormone artificial pancreas and a low glucose suspend algorithm. In addition to the dual hormone therapy, this integrated system includes a continuous glucose monitor ("CGM"), an infusion pump, and a control algorithm that actuates the pump based upon real time CGM data. Study results are expected in the first half of 2019.
"The goal in researching our liquid stable glucagon formulation as part of a dual-hormone closed-loop mated system is to overcome the limitations of current dry-powder glucagon formulations in automated pump systems to manage diabetes; this trial will help us better understand the potential application of our ready-to-use glucagon formulation," said Paul R. Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals. "Our research collaboration with OHSU and JDRF is an important opportunity to determine how a dual hormone artificial pancreas may help advance the standard of care for people with diabetes."