Data from a Phase 2 study in congenital hyperinsulinism (CHI) shared
at ENDO 2019 and a budget impact model presented at AMCP reinforce the
utility of Xeris’ ready-to-use, liquid-stable glucagon
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 it is presenting data on its developmental ready-to-use
(RTU) room-temperature stable liquid glucagon at two medical conferences.
“Our R&D efforts continue to provide support for the value of our novel
formulation technology platform for not only patients and providers, but
for payers and healthcare systems as well,” said Paul R. Edick, Chairman
and Chief Executive Officer of Xeris Pharmaceuticals. “We continue to
advance our pipeline to understand additional potential applications for
our ready-to-use, room-temperature stable liquid glucagon, particularly
in high-needs areas like congenital hyperinsulinism, in which proper
glucose supplementation is critical to prevent severe hypoglycemia and
neurologic injury in very young patients.”
ENDO 2019: A Phase 2 Comparison of a Stable Liquid Glucagon to
Placebo for the Treatment of Congenital Hyperinsulinism (Session
P11: SAT-272)
Xeris will present the first data from its Phase 2 study of RTU,
room-temperature stable liquid glucagon for congenital hyperinsulinemia
(CHI) during ENDO 2019, the Endocrine Society’s annual meeting, March
23-26 in New Orleans, LA. As part of this randomized, placebo-controlled
study, five patients with CHI under 1 year of age were enrolled to
receive Xeris’ RTU glucagon delivered continuously through an Omnipod®
infusion pump to prevent hypoglycemia and to lower supplemental glucose
requirements, via reductions in intravenous glucose infusion rates
(GIR). Treated patients had a positive clinical response compared to
those receiving placebo, and follow-up open-label treatment resulted in
a clinically meaningful response in all evaluable patients.
The full data will be shared during an oral presentation scheduled for
March 23, 1:00-3:00 pm CDT.
AMCP: “A Ready-To-Use Liquid Glucagon Rescue Pen for Severe
Hypoglycemia Demonstrates Reduced Healthcare Payer Costs in a Budget
Impact Model.” (Abstract E11, Published in JMCP
Supplement)
Results of a Xeris budget impact model on the estimated potential
reduction in costs associated with use of its RTU room-temperature
stable liquid glucagon will be presented in a poster during the Academy
of Managed Care Pharmacy’s AMCP Managed Care & Specialty Pharmacy Annual
Meeting, March 25-28 in San Diego, CA. The model was developed to
estimate the economic impact of open coverage of Gvoke HypoPen™ (Xeris’
ready-to-use, room-temperature stable liquid glucagon in an
auto-injector) for the treatment of severe hypoglycemia events as an
alternative to currently marketed glucagon emergency kits (GEKs). With
its positive functional efficacy profile, the results of the model
illustrate the potential financial benefits for open coverage of
glucagon rescue pen (GRP). The health utilization data also supports
physicians to increase patient access to completed and filled glucagon
prescriptions, in order to optimize patient outcomes. Results of the
analysis indicate that significant overall cost savings may be achieved
with use of the Xeris GRP.
A New Drug Application (NDA) for Xeris’ lead product candidate, Gvoke
HypoPen™ for the treatment of severe hypoglycemia, is currently under
review with the U.S. Food and Drug Administration (FDA), with a decision
expected during Q2 2019.
Omnipod® is a registered trademark of Insulet Corporation.
About Congenital Hyperinsulinism (CHI)
CHI is a very rare genetic disorder that affects 1 in 25,000 to 50,000
babies. It causes insulin cells of the pancreas, called beta cells, to
secrete too much insulin. Excess insulin causes low plasma sugar
(hypoglycemia). Common symptoms include irritability, sleepiness,
lethargy, excessive hunger, and rapid heart rate. CHI can cause
persistent hypoglycemia in newborn babies and children. Hypoglycemia can
be very dangerous because the brain needs a constant source of sugar. If
the brain doesn’t get the sugar it needs, prolonged and extremely low
blood sugar (severe hypoglycemia) can lead to seizures, coma, brain
damage, and possibly death.
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 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