CHICAGO–(BUSINESS WIRE)–Xeris Pharmaceuticals, Inc. (Nasdaq: 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.
About Glucagon
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.
Forward-Looking Statements
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.
The Company intends to use the investor relations portion of its website
as a means of disclosing material non-public information and for
complying with disclosure obligations under Regulation FD.
Contacts
Xeris Investor Contact
Allison Wey
Senior Vice
President, Investor Relations and Corporate Communications
awey@xerispharma.com
312-736-1237
Xeris
Media Contact
media@xerispharma.com