Xeris Pharmaceuticals, Inc. (XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that it has now begun dosing patients in a Phase 2 trial with its ready-to-use, room-temperature stable liquid glucagon in patients with Type 1 diabetes who experience episodes of exercise-induced hypoglycemia (EIH).
“Many individuals with diabetes treated with insulin experience EIH and the complexity of managing it is a major barrier to the adoption of regular physical activity. And unfortunately, today there are no approved therapies to prevent EIH. This research will help us understand the potential for ready-to-use glucagon to offer real-world benefit in reducing or preventing these challenging events during exercise,” said Dr. Ronnie Aronson, MD, FRCPC, FACE, endocrinologist and chief medical officer of LMC Diabetes & Endocrinology, Toronto, Canada. Dr. Aronson is the principal investigator on the EIH trial.
This Phase 2 study will evaluate Xeris’ ready-to-use glucagon as a pre-treatment to prevent exercise-induced hypoglycemia in 48 patients with Type 1 diabetes who receive daily insulin treatment via a subcutaneous infusion pump. In the two-period cross-over comparison study, patients will receive ready-to-use glucagon or placebo before at least 45 minutes of moderate or high intensity aerobic exercise in a clinical research center. Additional data will then be collected via a parallel comparison in an outpatient setting with a similar regimen involving at least 30 minutes of aerobic exercise performed by subjects 3-5 times per week for 12 weeks.
Xeris expects top-line results from the study in the second half of 2019. For more information, visit clinicaltrials.gov, identifier NCT03841526.
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). Leveraging XeriSol™, one of Xeris’ two proprietary formulation technology platforms, Xeris has the potential to provide the first ready-to-use, room-temperature stable liquid glucagon for use by people with diabetes and other indications to prevent or manage various forms of hypoglycemia and improve glucose control.
About Severe Hypoglycemia
Hypoglycemic events of any severity are a daily concern for people with diabetes. Mild or moderate hypoglycemia can occur multiple times a month. Severe hypoglycemia is characterized by severe cognitive impairment, requiring external assistance for recovery, and can be extremely frightening for patients and caregivers. Severe hypoglycemia can result in cardiovascular disease, seizure, coma, and, if left untreated, death. These severe hypoglycemic events can occur multiple times a year. Such events require emergency assistance from another person or caregiver such as a family member, friend, or co-worker.
About Xeris Pharmaceuticals, Inc.
Xeris is a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize 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 (SC) and intramuscular (IM) delivery of highly-concentrated, non-aqueous, ready-to-use formulations of peptides, small molecules, proteins, and antibodies using commercially available syringes, auto-injectors, multi-dose pens, and infusion pumps. XeriSol™ and XeriJect™ have the potential to offer distinct advantages over existing formulations of marketed and development-stage products, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) 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. Further information about Xeris can be found at www.xerispharma.com.
Any statements in this press release about future expectations, plans and prospects for Xeris Pharmaceuticals, Inc., including statements concerning the timing or likelihood of approval by the FDA of its NDA for its glucagon pen, the market and therapeutic potential of its product candidates, the timing or likelihood of commercialization of our product candidates, the potential utility of its formulation platforms and other statements containing the words "will," "would," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, without limitation, the regulatory approval of its product candidates, its ability to market and sell its products, if approved, and other factors discussed in the "Risk Factors" section of the most recently filed Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in Xeris’ subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Xeris expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
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