Rebound hypoglycemia observed in the placebo
arm with oral glucose tablet use; No rebound hypoglycemia observed
in the RTU glucagon treatment arm
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty
pharmaceutical company leveraging its novel formulation platforms
to develop and commercialize ready-to-use injectable and infusible
drug formulations, today announced positive findings from the
outpatient stage of a Phase 2 proof-of-concept study of its
developmental ready-to-use (RTU) glucagon in patients who
experience postprandial hypoglycemic episodes following bariatric
surgery.
This was a Phase 2 prospective, randomized, placebo-controlled,
double-blind proof-of-concept study that included an in-clinic
stage followed by a 12-week outpatient stage. Subjects were
randomly assigned to receive RTU glucagon or placebo during two
separate meal challenges in an in-clinic stage crossover design,
and then enter a parallel design outpatient stage where they were
assigned to an investigational product for 12 weeks. In this study,
subjects self-administered a mini dose (300 µg) of RTU glucagon or
placebo when they experienced hypoglycemia symptoms (e.g., anxiety,
nausea, sweating, tremors, palpitations), and blood glucose
response was measured after the study drug is self-administered. In
situations where hypoglycemia (blood glucose ≤ 70 mg/dl) is present
at mini-dosing or continues after treatment, oral glucose tabs were
recommended in addition to the study drug. For more information,
visit www.clinicaltrials.gov Identifier: NCT03770637
Results from the 12 subject, 12-week outpatient stage recorded
more than 200 postprandial hypoglycemia episodes across both
treatment arms. Subjects frequently experienced postprandial
episodes within 90-120 minutes after finishing meals and were able
to successfully self-administer RTU glucagon during these events.
Similar to the in-clinic stage, the sole use of a 300 µg RTU
glucagon was adequate to restore or maintain normal blood glucose
levels within 15 minutes of administration and maintained up to 120
minutes. During episodes when blood sugar was >70mg/dL at drug
dosing, RTU glucagon and placebo were comparable in maintaining
blood sugar within normal levels, and RTU glucagon did not elicit
hyperglycemia. During episodes when blood sugar was <70 mg/dL at
drug dosing and without the use of glucose tabs, RTU glucagon
successfully restored blood glucose levels to normal levels (blood
sugar ≥70 mg/dL) within 15 minutes, at a higher frequency when
compared to placebo (91% versus 73%). When failures were observed,
subjects in both treatment arms exhibited near-normal
counterregulatory responses to hypoglycemia, sufficient to avoid
severe hypoglycemia.
Subjects’ use of glucose tablets, both during and after drug
dosing as a follow-on rescue, was observed only within the placebo
treatment arm. In this placebo arm, glucose tablet use during
postprandial hypoglycemia episodes resulted in rebound hypoglycemia
(29.4%). Rebound hypoglycemia was not observed in the RTU glucagon
treatment arm.
Treatment emergent adverse events with RTU glucagon were
comparable to placebo, including negligible injection site
reactions. The most common related AE was nausea (16.7%) and
vomiting (8.3%) that was mild in severity and self-limited. RTU
glucagon (300 μg) appears safe and well tolerated, and no serious
adverse events occurred.
“Post-bariatric hypoglycemia (PBH) is a rare complication of
bariatric surgery that can significantly diminish the quality of
life for those affected. Once diagnosed, the goal of PBH treatment
is to reduce the frequency and severity of hypoglycemic events
after meals. However, managing PBH is complex because patients
often fail dietary intervention and we do not have effective
pharmacotherapy,” said Dr. Helen Lawler, MD, endocrinologist,
Assistant Professor, Endocrinology, Diabetes and Metabolism at the
University of Colorado School of Medicine. “Patients feel
frustrated because of the limited therapeutic options, where
unfortunately, today there are no approved therapies to treat PBH.”
Dr. Lawler continued, “This PBH research will help us understand
the potential for ready-to-use glucagon to offer real-world
benefits such as the avoidance of oral carbohydrates to treat
postprandial hypoglycemia, reduced weight gain, and the reduction
of rebound hypoglycemia.”
“We are encouraged by the results of the completed
proof-of-concept PBH study. The first half of this study
demonstrated the utility of liquid, stable, ready-to-use glucagon
in conditions beyond rescue for severe hypoglycemia, and
demonstrating safety and effectiveness in situations that require
self-administration by the patient,” said Paul R. Edick, Xeris’
Chairman and CEO. “We believe the completed outpatient stage study
further establishes the safety profile and utility for mini dosing
RTU glucagon in a real-world setting. Further evaluation of RTU
glucagon in PBH is warranted, especially in those who manifest
blunted counterregulatory responses to hypoglycemia, and in
refractory disease.” Mr. Edick continued, “We anticipate an
end-of-phase 2 meeting with the FDA later this year to discuss a
clinical path forward for this program.”
About Post-Bariatric Hypoglycemia (PBH)
Approximately 200,000 weight loss (bariatric) surgeries are
performed annually in the United States. Hypoglycemia that occurs
after bariatric and other forms of upper gastrointestinal surgery
is a condition called post-bariatric hypoglycemia (PBH). It usually
occurs >6 months to 8 years after surgery and is an uncommon and
rarely reported metabolic complication that can be severe and
disabling for some patients. Hypoglycemia episodes from PBH occur
1-3 hours after meals (postprandial hypoglycemia), often at a
frequency of >10 times per month. Persistent or unrecognized
hypoglycemia from PBH can progress to severe hypoglycemia (blood
glucose <54 mg/dL) with symptoms such as loss of consciousness,
seizures, coma, and even death. When postprandial hypoglycemia
episodes in PBH occur, they can be difficult to acutely treat with
oral carbohydrates alone, because an overcompensation with oral
carbohydrates can frequently trigger a subsequent hypoglycemia
episode (rebound hypoglycemia).
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
conditions to prevent or manage various forms of hypoglycemia and
improve glucose control.
About Xeris Pharmaceuticals, Inc.
Xeris (Nasdaq: XERS) is a specialty pharmaceutical company
delivering innovative solutions to simplify the experience of
administering important therapies that people rely on every day
around the world. With a novel technology platform that enables
ready-to-use, room-temperature stable formulations of injectable
and infusible therapies, the company is advancing a portfolio of
solutions in various therapeutic categories, including its first
commercial product, Gvoke™. Its proprietary XeriSol™ and XeriJect™
formulation technologies have the potential to offer distinct
advantages over conventional product formulations, including
eliminating the need for reconstitution, enabling long-term,
room-temperature stability, significantly reducing injection
volume, and eliminating the requirement for intravenous (IV)
infusion. With Xeris’ technology, new product formulations are
designed to be easier to use by patients, caregivers, and health
practitioners and help reduce costs for payers and the healthcare
system.
Xeris is headquartered in Chicago, IL. For more information,
visit www.xerispharma.com, or follow us on Twitter, LinkedIn or
Instagram.
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Xeris Pharmaceuticals, Inc., including
statements regarding the therapeutic potential of its product
candidates, the timing of clinical trials and results, and other
statements containing the words “plans”, “expects”, “anticipates”,
"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, the impact of
Covid-19 on its business operations 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.
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Xeris Investor Contact Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com 312-736-1237
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