Xeris Pharmaceuticals and OHSU Conducting Artificial Pancreas Clinical Trial Using Xeris’ Novel Ready-to-Use Liquid Glucagon

From Startup Xeris Pharmaceuticals

Link to Full Article: https://investors.xerispharma.com/news-releases/news-release-details/xeris-pharmaceuticals-and-ohsu-conducting-artificial-pancreas

Patients enrolling in Phase 1 clinical trial using Xeris’
ready-to-use liquid glucagon formulation as part of a fully integrated,
dual-hormone closed-loop system
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,
announced today that Jessica Castle, M.D., an associate professor of
medicine in the OHSU School of Medicine and OHSU Harold Schnitzer
Diabetes Health Center in Portland, Oregon, is conducting a clinical
trial with a dual-hormone artificial pancreas using Xeris’ ready-to-use
liquid glucagon to evaluate a new closed-loop algorithm.

Managing diabetes requires ongoing monitoring of blood glucose levels
and regular intervention with glucose and insulin – a burdensome process
for the over five million people on insulin in the United States.
Automated insulin delivery (AID) systems available today can dial up and
down or stop the delivery of insulin. They are limited in their ability
to co-deliver glucagon, as current dry-powder glucagon formulations must
be used immediately because they begin to degrade after reconstitution.

Xeris’ ready-to-use liquid glucagon is room-temperature stable over
extended periods of time, thereby enabling a dual-hormone artificial
pancreas system to be possible. The ability to co-administer both
insulin and stable liquid glucagon in one system may reduce the risk of
hypoglycemia by mirroring the body’s normal glucose control, which is
especially important during periods of exercise.

Supported by funding from JDRF, the leading global organization funding
type 1 diabetes (T1D) research, OHSU is conducting a Phase 1
single-center, randomized, three-way, controlled, crossover clinical
study to test the efficacy of a new closed-loop algorithm for managing
blood glucose in people with T1D before and after exercise.

“JDRF is excited to support OHSU’s research into ready-to-use liquid
glucagon,” said Marlon Pragnell, Ph.D., JDRF associate director of
research. “This program has the potential to change the way millions of
active individuals with T1D monitor and treat their glucose levels.”

The purpose of this study is to determine whether a dual hormone
artificial pancreas using Xeris’ ready-to-use liquid glucagon with an
exercise detection algorithm outperforms both single hormone artificial
pancreas and a low glucose suspend algorithm. In addition to the dual
hormone therapy, this integrated system includes a continuous glucose
monitor (“CGM”), an infusion pump, and a control algorithm that actuates
the pump based upon real time CGM data. Study results are expected in
the first half of 2019.

“The goal in researching our liquid stable glucagon formulation as part
of a dual-hormone closed-loop mated system is to overcome the
limitations of current dry-powder glucagon formulations in automated
pump systems to manage diabetes; this trial will help us better
understand the potential application of our ready-to-use glucagon
formulation,” said Paul R. Edick, Chairman and Chief Executive Officer
of Xeris Pharmaceuticals. “Our research collaboration with OHSU and JDRF
is an important opportunity to determine how a dual hormone artificial
pancreas may help advance the standard of care for people with diabetes.”

For further information on the clinical trial see ClinicalTrials.gov
Identifier: NCT03424044.

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).

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, proteins, antibodies, and small molecules using
commercially available syringes, auto-injectors, multi-dose pens, and
infusion pumps. Xeris’ platforms have the potential to offer distinct
advantages over existing formulations of marketed and development-stage
products. In particular, XeriSol™ and XeriJect™ have the potential to
eliminate the need for reconstitution, enable long-term,
room-temperature stability, significantly reduce injection volume, and
eliminate 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 our NDA
for our Glucagon Rescue Pen, the Company’s expectations related to the
use of proceeds from its IPO, the market and therapeutic potential of
our product candidates and the potential utility of our formulation
platform 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 our product candidates, our ability to market and sell our
products, if approved, and other factors discussed in the “Risk Factors”
section of the final prospectus related to Xeris’s initial public
offering filed with the Securities and Exchange Commission pursuant to
Rule 424(b) of the Securities Act, as well as discussions of potential
risks, uncertainties, and other important factors in Xeris’s 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20180817005037/en/
Source: Xeris Pharmaceuticals, Inc.

Xeris Pharmaceuticals, Inc.Investor ContactAllison WeySenior
Vice President, Investor Relations and Corporate Communicationsawey@xerispharma.com312-736-1237orMedia

Please visit their site for more information: Xeris Pharmaceuticals.com

All,Biotechnology,Healthcare News,Startup News
2018-08-18 05:00:21