Data demonstrate proof-of-concept showing a
once weekly subcutaneous injection of XP-8121 provides similar
exposure at steady-state as daily oral Synthroid®
Simulation model implies dose conversion factor
of 4X
XP-8121 in healthy volunteers was generally
well tolerated at all doses
Data supports further development in patients
with congenital or acquired hypothyroidism who require thyroid
hormone replacement
FDA End-of-Phase 1 interaction expected by
year-end
Company to host conference call and webcast
today at 8:30 a.m. ET
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented
biopharmaceutical company committed to improving patient lives by
developing and commercializing innovative products across a range
of therapies, today announced topline results from its Phase 1
study of subcutaneous (SC) levothyroxine (XP-8121) in healthy adult
volunteers. Using its XeriSol™ technology, the Company is
developing a novel formulation of levothyroxine sodium (SC
injection) to potentially mitigate many of the challenges
associated with oral formulations of levothyroxine.
The Phase 1 study was a randomized, open-label, crossover study
conducted in 60 healthy adults. The study was designed to evaluate
the pharmacokinetics, dose proportionality and safety and
tolerability of 600 μg, 1200 μg, and 1500 μg of XP-8121 following
SC administration and to evaluate the relative bioavailability of
600 μg SC XP-8121 versus 600 μg oral (PO) levothyroxine (Synthroid
®). Single dose data from this study were used to develop a
population pharmacokinetic model to simulate steady-state exposure
(AUC) following weekly SC dosing of XP-8121 or daily PO dosing of
Synthroid and to determine the target dose conversion at
steady-state from Synthroid PO to XP-8121 SC.
“Oral levothyroxine has been the standard of care treatment for
hypothyroidism for many years, and it is one of the most prescribed
medicines in the United States, generating more than 100 million
prescriptions per year. The Phase 1 study results offer initial
proof of concept that our novel subcutaneous formulation of
levothyroxine has the potential to provide patients with a
once-weekly dosing, thereby potentially improving treatment
adherence, as well as bypassing the gastrointestinal (GI) tract,
thereby mitigating limitations of oral therapy,” said Paul R.
Edick, Xeris’ Chairman and CEO. “We have requested a meeting with
the FDA and expect feedback by the end of the year.”
“We are very encouraged with the results of the Phase 1 study of
XP-8121, our subcutaneous injection of levothyroxine. The data show
that subjects receiving XP-8121 SC have slower absorption, lower
peak plasma, and higher extended exposure compared to Synthroid PO
at the comparable dose of 600 μg. In addition, exposure was
proportional over the range of ascending XP-8121 doses studied.
Simulations based on the population pharmacokinetic model indicate
that exposure from weekly XP-8121 1200 μg SC doses overlaps daily
Synthroid PO 300 μg suggesting a dose conversion factor of 4x,”
said Ken Johnson, PharmD, Xeris’ Senior Vice President, Global
Development and Medical Affairs. “Importantly, single SC doses of
XP-8121 at all doses were safe and well tolerated and no XP-8121
studied dose was different from Synthroid 600 μg PO with respect to
the safety findings.”
Conference Call and Webcast Details
Xeris will host a conference call and webcast today, Thursday,
October 20, 2022, at 8:30 a.m. Eastern Time. To pre-register for
the conference call please use this link:
https://www.netroadshow.com/events/login?show=f4a7da25&confId=43411
After registering, a confirmation email will be sent, including
dial-in details and a unique code for entry. The Company recommends
registering a minimum of ten minutes prior to the start of the
call. Following the conference call, a replay will be available
until Thursday, November 8, 2022, at US: 1 929 458 6194, US Toll
Free: 1 866 813 9403, UK: 0204 525 0658, Canada: 1 226 828 7578, or
all other locations: +44 204 525 0658 Access Code: 573410. In
addition, a live audio of the conference call will be available as
a webcast. To join the webcast, please visit “Events” on investor
relations page of the Company’s website at www.xerispharma.com or
use this link https://events.q4inc.com/attendee/711397177
About Hypothyroidism
Hypothyroidism, or underactive thyroid, happens when your
thyroid gland doesn't make enough thyroid hormones to meet your
body's needs. Your thyroid is a small, butterfly-shaped gland in
the front of your neck. It makes hormones that control the way the
body uses energy. These hormones affect nearly every organ in your
body and control many of your body's most important functions. For
example, they affect your breathing, heart rate, weight, digestion,
and moods. Without enough thyroid hormones, many of your body's
functions slow down.
About Levothyroxine
Therapeutically, levothyroxine is administered when the body is
deficient in the endogenous hormone. Administration of
levothyroxine is thus indicated for acquired thyroid disease
(primary hypothyroidism), in cases of decreased secretion of TSH
from the anterior pituitary gland (secondary hypothyroidism), and
in cases of decreased secretion of TRH from the hypothalamus
(tertiary hypothyroidism) and for congenital hypothyroidism. In
most patients, hypothyroidism is a permanent condition requiring
lifelong treatment. The goal of therapy is restoration of the
euthyroid state, which can reverse the clinical manifestations of
hypothyroidism and significantly improve quality of life.
About XeriSol™
The proprietary XeriSol™ non-aqueous formulation technology
platform is designed to address the limitations of aqueous
formulations for peptide and small molecule drugs. The solutions
are formulated using biocompatible, non-aqueous solvents that
impart high stability and solubility to drugs allowing for
development of room temperature stable, ready-to-use formulations.
XeriSol™ formulations have been used extensively in global
commercial products (Gvoke®/Ogluo®) and clinical trials. The
technology is protected by an extensive patent estate, trade
secrets and know-how, and it is available for licensing.
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical
company committed to improving patient lives by developing and
commercializing innovative products across a range of therapies.
Xeris has three commercially available products; Gvoke®, a
ready-to-use liquid glucagon for the treatment of severe
hypoglycemia, Keveyis®, the first and only FDA-approved therapy for
primary periodic paralysis, and Recorlev® for the treatment of
endogenous Cushing’s syndrome. Xeris also has a pipeline of
development programs to extend the current marketed products into
important new indications and uses and bring new products forward
using its proprietary formulation technology platforms, XeriSol™
and XeriJect™, supporting long-term product development and
commercial success.
Xeris Biopharma Holdings is headquartered in Chicago, IL. For
more information, visit www.xerispharma.com, or follow us on
Twitter, LinkedIn, or Instagram.
Forward-looking Statement
Any statements in this press release about future expectations,
plans and prospects for Xeris Biopharma Holdings, Inc., including
the development of a sub-cutaneous formulation of levothyroxine,
the market and therapeutic potential of Xeris’ products and product
candidates, expectations regarding clinical data or results from
planned clinical trials, the timing of clinical trials, the timing
or likelihood of regulatory approval and commercialization of its
product candidates, the timing or likelihood of expansion of
current marketed products into new indications and uses or into
additional markets, the potential utility of its proprietary
formulation technology platforms, and other statements containing
the words “expected,” “will,” “would,” “continue,” and similar
expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995.
These forward-looking statements are based on numerous assumptions
and assessments made in light of Xeris’ experience and perception
of historical trends, current conditions, business strategies,
operating environment, future developments, and other factors it
believes appropriate. By their nature, forward-looking statements
involve known and unknown risks and uncertainties because they
relate to events and depend on circumstances that will occur in the
future. Various factors could cause Xeris’ actual results,
performance or achievements, industry results and developments to
differ materially from those expressed in or implied by such
forward-looking statements, including the impact of COVID-19 on our
business operations and clinical activities, our ability to fund
our product development programs or commercialization efforts,
whether our clinical trials demonstrate efficacy and safety to the
satisfaction of the FDA or other regulatory authorities, and
whether our products will achieve and maintain market acceptance.
No assurance can be given that our expectations will be realized
and persons reading this communication are, therefore, cautioned
not to place undue reliance on these forward-looking statements.
Additional information about economic, competitive, governmental,
technological, and other factors that may affect Xeris is set forth
in the "Risk Factors" section of the most recently filed Quarterly
Report on Form 10-Q filed with the U.S. Securities and Exchange
Commission, the contents of which are not incorporated by reference
into, nor do they form a part of, this communication.
Forward-looking statements in this communication are based upon
information available to Xeris, as of the date of this
communication and, while believed to be reasonable, actual results
may differ materially. Subject to any obligations under applicable
law, Xeris does not undertake any obligation to update any
forward-looking statement whether as a result of new information,
future developments or otherwise, or to conform any forward-looking
statement to actual results, future events, or to changes in
expectations.
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version on businesswire.com: https://www.businesswire.com/news/home/20221020005248/en/
Investor Contact Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com 312-736-1237
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