Xeris Pharmaceuticals Announces Additional Positive Outcomes from a Global Phase 3 Clinical Trial of Its Investigational Ready-to-Use Glucagon

June 17, 2019 Off By BusinessWire

Findings will support application for European marketing
authorization and augment body of data supporting efficacy and utility
of its ready-to-use, stable liquid 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 positive findings from a global Phase 3 trial of its
ready-to-use (RTU) room-temperature stable liquid glucagon conducted in
Europe and North America.

The Phase 3, multi-center, randomized controlled, non-inferiority study
was conducted among 132 adults with type 1 diabetes to evaluate the
Xeris RTU glucagon auto-injector as a treatment for severe hypoglycemic
events as compared with Novo Nordisk’s GlucaGen® HypoKit®. The results
demonstrated comparable efficacy between the two groups for achieving a
plasma glucose of >70 mg/dl or ≥20 mg/dl increase in plasma glucose
concentration within 30 minutes of glucagon administration. The study
also found that time to resolution of hypoglycemia symptoms as well as
time to resolution of the overall feeling of hypoglycemia was comparable
between Xeris RTU glucagon and the marketed emergency kit. Overall, no
safety or tolerability concerns were noted. (EudraCT Number
2018-002661-19, NCT03738865)

“As the population with Type 1 diabetes continues to grow in Europe, we
need to ensure that patients and caregivers are equipped with effective,
rapid-onset and easily administered solutions during potentially severe
episodes of hypoglycemia,” said Thomas Pieber, MD, Professor of
Medicine, Chair of the Division of Endocrinology and Diabetology at the
Medical University of Graz in Austria, and lead investigator of the
study. “Based on the results of this study, the Xeris ready-to-use,
stable liquid glucagon may be an effective alternative to current
options to effectively control these events, giving confidence to
patients and their caregivers that they can quickly intervene during
emergency settings.”

“This is our fourth Phase 3 trial with Xeris’ ready-to-use glucagon. It
provides further support of the effectiveness and utility of our
ready-to-use glucagon candidate, demonstrating again that it provides an
effective alternative to currently available options for severe
hypoglycemia. We are confident in the profile of this treatment based on
the rich data we’ve collected over the course of multiple trials,” said
Paul R. Edick, Chairman and Chief Executive Officer of Xeris
Pharmaceuticals. “We also have a number of ongoing clinical trials to
evaluate our liquid stable glucagon in other important potential
indications.”

A New Drug Application (NDA) for the investigational product, to be
branded as the Gvoke HypoPen™ in the US, is currently under review with
the U.S. Food and Drug Administration (FDA), with a decision expected
September 10, 2019.

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.