Phase 2 (FDA Meeting)
Amp Volatility Score
Catalyst Info & Data Links
TITLE: Ready-to-use (RTU) glucagon for Post-Bariatric Hypoglycemia
ClinicalTrials.gov (NCT03770637): Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
WHAT IS THE CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
05-22-2020 Findings From the Outpatient Portion of a Phase 2 Proof-of-Concept Study of Its Developmental Ready-to-Use (RTU) Glucagon in Patients at Risk of Postprandial Hypoglycemia Following Bariatric Surgery
2020: A Randomized, Placebo-Controlled Double-Blind Trial of a Closed-Loop Glucagon System for Postbariatric Hypoglycemia. The Journal of Clinical Endocrinology & Metabolism, 105(4), e1260-e1271.
MECHANIMS OF ACTION
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 conditions to prevent or manage various forms of hypoglycemia and improve glucose control.
There are approximately 200K bariatric surgeries per year in the US
Estimates of incidence of PBH differ across experts, but are consistently <1%
PBH can occur 6 months to 8 years after bypass surgery
Updated by HC
XERS, ready-to-use (RTU) glucagon, Post-Bariatric Hypoglycemia, bariatric surgeries, low blood glucose sugar
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