Xeris Pharmaceuticals Awarded Phase I-II NIH SBIR Fast Track Grant to Advance Stable, Non-Aqueous Glucagon for Treatment of Congenital Hyperinsulinism, an Orphan Disease

Austin, Texas, April 14, 2015 (GLOBE NEWSWIRE) -- Xeris Pharmaceuticals, Inc. (“Xeris”), an Austin-based, emerging biopharmaceutical company developing patient-friendly injectable treatments for diabetes and other diseases, was awarded a Small Business Innovation Research (SBIR) Phase I grant for $485,403 to advance the company's room-temperature stable, non-aqueous glucagon formulation for the treatment of Congenital Hyperinsulinism (CH). The funding represents the initial installment of a Phase I-II Fast Track SBIR grant, with the potential for a total award of approximately $2 million with Phase II funding. The grant was awarded on March 24 by the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), an institute of the National Institutes of Health (NIH) which funds research on diabetes and other metabolic diseases.

Grant funding will support drug supplies manufacturing, preclinical studies, regulatory development, and a foundational clinical trial. The clinical trial will be conducted at two hospitals in the US that are renowned treatment centers for patients with CH. Studies at Cook Children’s Medical Center in Fort Worth, TX, will be led by co-Principal Investigator, Dr. Paul Thornton, a pediatric endocrinologist and Medical Director of Cook Children’s Endocrine and Diabetes Program and Congenital Hyperinsulinism Center. Studies at The Children’s Hospital of Philadelphia, in Philadelphia, PA will be led by Dr. Diva D. De Leon-Crutchlow, a pediatric endocrinologist and Director of the Congenital Hyperinsulinism Center. For patients with CH, the pancreas secretion of insulin is not appropriately regulated, which results in severe-persistent hypoglycemia (low blood sugar) that can cause brain damage, blindness and be life-threatening. The project aims to use a glucagon infusion pump to maintain blood glucose levels at near normal levels and thus prevent hypoglycemia, without the requirement of an intravenous infusion that is often used in the hospital to treat these children. Once patients are stabilized in the hospital, the ultimate goal of this program would be to use the glucagon pump to enable discharge of the patient into an outpatient setting under care of the parents and/or nurse.

“Working with the NIDDK and Drs. Thornton and De Leon-Crutchlow in the development of continuous subcutaneous infusion of Xeris glucagon administered through a pump will allow us to potentially develop an innovative product for prevention of hypoglycemia in this patient population” said Dr. Steven Prestrelski, Chief Scientific Officer for Xeris Pharmaceuticals and Principal Investigator. “This is a significant unmet medical need and the SBIR funding will help advance our novel formulation and delivery system for glucagon.”

Grant Number: 1R44DK105691-01
Project Name: CSI Glucagon for Treatment of Congenital Hyperinsulinism

About Congenital Hyperinsulinism
Congenital hyperinsulinism (CH) is the most frequent cause of severe, persistent hypoglycemia (very low blood sugar) in newborn babies and children. It occurs in approximately 1/25,000 to1/50,000 births in the United States. About 60% of neonates with CH develop hypoglycemia during the first month of life. An additional 30% will be diagnosed later in the first year and the remainder after that. Congenital hyperinsulinism is a condition that causes individuals to have abnormally high levels of insulin, a hormone that helps control blood sugar levels. Infants and children with CH have severe-persistent hypoglycemia. In infants and young children, these episodes are characterized by a lack of energy, irritability, difficulty feeding and may lead to seizures and breathing difficulties. Repeated episodes of low blood sugar can result in permanent seizure disorder, learning disabilities, cerebral palsy, blindness or even death.

About Glucagon
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 keeps blood glucose at the right level in healthy individuals. In patients with CH, genetic defects cause the pancreas to continuously overexpress insulin. More commonly, glucagon is associated with people with diabetes who are dependent on insulin, where this control system is disrupted and insulin must be injected prior to meals to avoid high levels of blood glucose (hyperglycemia). The opposite effect of low blood glucose (hypoglycemia) is also prevalent in this population, resulting from too much insulin or exercise. If untreated, this leads to severe hypoglycemia, a serious condition and can cause seizures, coma, potential brain injury and, death. Xeris’ proprietary glucagon formulation has the potential to provide the first soluble, room temperature stable, pump-delivered glucagon for continuous infusion to prevent severe-persistent hypoglycemia associated with CH.

About Xeris Pharmaceuticals, Inc.
Xeris is an Austin, Texas-based, specialty biopharmaceutical company developing improved and differentiated, injectable therapeutics for multiple indications including diabetes. The company's proprietary non-aqueous formulation technologies allow for the delivery of highly concentrated, non-aqueous, ready-to-inject suspension and solution formulations of peptides, proteins, antibodies and small molecules. Xeris' proprietary formulation approach offers distinct advantages over existing products and formulations including: up to 1000-fold lower injection volumes, eliminating the need for reconstitution and refrigeration, with extended room temperature shelf-life stability, all of which can lead to products that are easier to use by patients, caregivers, health practitioners, and that can reduce costs for payers and the healthcare system. For more information, please visit the Xeris website at: www.xerispharma.com

Michelle Bybee Xeris Pharmaceuticals, Inc. (512)478-2676 mbybee@xerispharma.com www.xerispharma.com

Source:Xeris Pharmaceuticals, Inc.