What is hypoglycemia?
Hypoglycemia is a condition in diabetics where glucose levels in the blood fall below normal levels leading to anxiety, sweating, tremors, palpitations, nausea, and pallor. Hypoglycemia also starves the brain of glucose, which is essential for proper brain function. Lack of glucose to the brain can cause symptoms ranging from headache, mild confusion, and abnormal behavior, to loss of consciousness, seizure, and coma with severe hypoglycemia. Severe hypoglycemia occurs when blood glucose levels fall so low that the assistance of another person is required to treat the condition with administration of carbohydrates, glucagon, or other rescue procedures. Lack of timely treatment can result in death. Sadly, 6%-10% of deaths of Type 1 diabetes each year are the result of severe hypoglycemic events left untreated [Cryer, PE, Diabetes December 2008 vol. 57 no. 12 3169-3176].
Severe hypoglycemia is a condition typically experienced by Type 1 and insulin-dependent Type 2 diabetics. The current standard of care is an injection of glucagon. Administration of glucagon with current products is a multiple-step process including assembly of the kit, reconstitution of the powdered glucagon by mixing with water, and manual administration of the dose with a needle and syringe. Glucagon is a polypeptide hormone secreted by the pancreas that raises blood glucose levels. Its effect is opposite to that of insulin, which lowers blood glucose levels. Glucagon causes the liver to rapidly convert stored glycogen (stored form of glucose) into glucose which is released into the bloodstream. Glucagon also stimulates the release of insulin, so that glucose can be taken up and used by insulin-dependent tissues. Glucagon and insulin are part of a feedback system that keeps blood glucose at the healthy levels.
The immediate market opportunity with glucagon is a ready-to-use rescue pen (G-Pen) for severe hypoglycemia in Type 1 and insulin-dependent Type 2 diabetics. Follow-on products for the treatment of hypoglycemia include a mini-dose pen (G-Pen Mini) for treatment of mild/moderate hypoglycemia as an alternative to the use of high sugar foods to alleviate mild/moderate hypoglycemia. Finally, Xeris will leverage its technology to develop a pump-based glucagon (G-Pump) formulation for use in a bi-hormonal pump model for the artificial pancreas. In this application, glucagon would be coupled with insulin in a dual-chamber pump and continuous glucose monitoring to provide fully closed-loop glycemic control.