European Medicines Agency Grants Orphan Drug Designation for Xeris’ Investigational Ready-to-Use Glucagon for the Treatment of Non-Insulinoma Pancreatogenous Hypoglycaemia Syndrome (NIPHS)
“PBH is a challenging complication of bariatric surgery with no reliable treatment today. We are evaluating whether intermittent administration of our ready-to-use liquid glucagon may more rapidly and effectively address PBH, instead of relying upon dietary controls or medications that reduce glucose surges,” said
Xeris is initiating a Phase 2 randomized, double-blind, placebo-controlled study of its ready-to-use liquid glucagon in patients with post-bariatric hypoglycemia (NCT03770637). In this study, up to 12 patients (aged 18 – 75) will receive the Xeris ready-to-use glucagon or placebo during episodes of postprandial hypoglycemia (occurring after a meal) and will be followed for 12 weeks. The primary endpoint is blood glucose recovery levels (targeting over 70 mg/dL). Initial results are expected in the first half of 2019. For more information, visit www.clinicaltrials.gov. This study follows a separate Phase 2a study conducted with collaborators at
About Post-Bariatric Hypoglycemia
Hypoglycemia typically does not present until two to three years after gastric bypass surgery. These hypoglycemic episodes are characterized by low blood sugars that occur two to three hours after a meal. Fasting hypoglycemia is typically not seen. The etiology seems to be excessive insulin secretion in response to the meal.
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.
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