XERS

Self-Administered Glucagon / ready-to-use (RTU) glucagon

Post-Bariatric Hypoglycemia

Phase 2 (FDA Meeting)

Exp Date

H1 2021

Amp Volatility Score

N/A

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?

  • H1 2021


PRIOR DATA/EVENTS

PRESS RELEASE


PUBLICATION

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.

MARKET

  • 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

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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