XERS

Gvoke RTU Micro™

Exercise-Induced Hypoglycemia

Stage (next event)

Expected Date

Phase 2

H1 2021

Catalyst Info & Data Links

TITLE: Gvoke RTU Micro™ for Exercise-Induced Hypoglycemia 

  • ClinicalTrials.gov (NCT03841526): Glucagon Ready-to-Use for the Prevention of Exercise-Induced Hypoglycemia During Aerobic Exercise in Adults With T1D


WHAT IS THE CATALYST EVENT?


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • H1 2021


PRIOR DATA/EVENTS

PRESS RELEASE

Mechanism of Action

MECHANISM 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.

MARKET

  • For persons with diabetes, especially with type 1 diabetes (T1D), the lack of pancreatic β-cell function leads to the requirement for exogenous insulin (introduced into the body by injection or infusion). Circulating levels of insulin consequently cannot be regulated endogenously and depend on the quantity and timing of insulin taken by the individual before exercise. Thus, insulin levels are often higher than they would be in the absence of diabetes, which has the result of limiting glucose production by the liver while stimulating glucose uptake by muscle, adipose, and liver cells for storage. As a result, blood glucose levels often decrease dramatically during physical activity for individuals with T1D unless carbohydrates are consumed before, during, and after exercise. This condition of low blood glucose with physical activity is known as Exercise-Induced Hypoglycemia (EIH).

Updated by HC

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