21 August 2018 - - 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 US-based specialty pharmaceutical company Xeris Pharmaceuticals, Inc.'s (NASDAQ: XERS) ready-to-use liquid glucagon to evaluate a new closed-loop algorithm, the company said.

Managing diabetes requires ongoing monitoring of blood glucose levels and regular intervention with glucose and insulin a burdensome process for the over 5m people on insulin in the United States. Automated insulin delivery 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 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.

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, 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.

Glucagon is a metabolic hormone secreted by the pancreas that raises blood glucose levels by causing the liver to rapidly convert glycogen (the stored form of glucose) into glucose, which is then released into the bloodstream.

Glucagon and insulin are two critical hormones in a glycemic control system that keep blood glucose at the right level in healthy individuals. In people with diabetes who are dependent on insulin, this control system is disrupted and insulin must be injected to avoid high levels of blood glucose (hyperglycemia).

The opposite effect, or low blood glucose (hypoglycemia), is also prevalent in this population due to dysregulated glucagon secretion. Severe hypoglycemia is a serious condition and can lead to seizures, coma, potential brain injury and, if untreated, death.

Glucagon is the standard of care for treating severe hypoglycemia. According to the American Diabetes Association, glucagon should be prescribed for all individuals at increased risk of clinically significant hypoglycemia, defined as blood glucose >54 mg/dL (3.0 mmol/L).

Xeris is a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialise 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, proteins, antibodies, and small molecules using commercially available syringes, auto-injectors, multi-dose pens, and infusion pumps. Xeris' platforms have the potential to offer distinct advantages over existing formulations of marketed and development-stage products.

In particular, XeriSol and XeriJect have the potential to eliminate the need for reconstitution, enable long-term, room-temperature stability, significantly reduce injection volume, and eliminate 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.