Targeting initiation of a Phase II study by 2H
2023
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 that, based on feedback from a Type C
meeting with the Food and Drug Administration (FDA), Xeris will
proceed with a Phase II study in patients for its novel formulation
of levothyroxine sodium (SC injection) as replacement therapy for
hypothyroidism. The Company anticipates initiating the study by the
second half of 2023.
“We received very productive feedback from the FDA on our
proposed clinical plan for our once weekly subcutaneous
levothyroxine and are in the process of clarifying some aspects of
the Phase II and Phase III recommendations. We believe we have
enough clarity to move forward with a Phase II study, which we
anticipate having up and running by the second half of 2023,” said
Paul R. Edick, Xeris’ Chairman and CEO.
“We are excited to commence our Phase II dose-finding study of
XP-8121 in 2023. The study will be designed to assess XP-8121 in
patients receiving oral thyroid replacement therapy to establish
the average once-weekly dose, accrue chronic safety data, and
facilitate a future Phase III program in consultation with the
FDA,” said Ken Johnson, PharmD, Xeris’ Senior Vice President,
Global Development and Medical Affairs.
In October, Xeris reported positive topline Phase I data of
XP-8121. 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. 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.
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 solutions 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 patients’ 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 feedback, regulatory approval, or
commercialization of its product candidates, the timing, likelihood
or nature 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/20221215005134/en/
Investor Contact Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com 312-736-1237
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