Novel formulation of levothyroxine sodium (SC
injection) to potentially mitigate many of the challenges
associated with oral formulations of levothyroxine.
Phase 2 study to establish the average
once-weekly dose, accrue additional safety data, and facilitate a
future Phase 3 program
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented
biopharmaceutical company committed to improving patients’ lives by
developing and commercializing innovative products across a range
of therapies, today announced that the first participant has been
dosed in a multi-center, open label, Phase 2 study of XP-8121 for
the treatment of adults with hypothyroidism.
“Oral levothyroxine is one of the most prescribed medicines in
the United States, generating more than 100 million prescriptions
per year. However, many patients experience one or more challenges
associated with the oral therapy. We believe that our novel SC
formulation of levothyroxine has the potential to provide patients
with a once-weekly dosing, thereby potentially improving treatment
adherence, as well as bypass the gastrointestinal (GI) tract,” said
Paul R. Edick, Xeris’ Chairman and CEO.
“We are excited to have dosed the first participant in our Phase
2 dose-finding study of XP-8121 and are actively recruiting
additional participants that meet the eligibility criteria. We
anticipate a lengthy recruitment period as enrolling stably dosed
patients with normal TSH on oral levothyroxine is challenging and
speaks further to the need of developing a once-weekly SC
injection,” said Kenneth E. Johnson, PharmD, Xeris’ Senior Vice
President, Global Development and Medical Affairs. “Depending upon
enrollment rates, we anticipate completing the study in the first
half of 2024.”
The Phase 2 study (NCT05823012) is a non-randomized, open-label,
single arm, self-controlled study of XP-8121 (levothyroxine sodium)
to determine a target dose conversion factor from stably dosed oral
levothyroxine to XP-8121 (levothyroxine sodium) in patients with
hypothyroidism and to assess the safety and tolerability of XP-8121
(levothyroxine sodium) after once-weekly subcutaneous injections.
This study includes the following periods: Screening, Titration
Period (2 to 8 weeks), and Maintenance Period (4 weeks). A
pharmacokinetic sub-study will be conducted for a subset of
patients during the Maintenance Period.
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 Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical
company committed to improving patients’ lives by developing and
commercializing differentiated and 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®, a proven therapy for primary
periodic paralysis; and Recorlev® for the treatment of endogenous
Cushing’s syndrome. Xeris has a diverse pipeline of development and
partnered programs using its formulation sciences, XeriSol™ and
XeriJect™, to support 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 Statements
Any statements in this press release about future expectations,
plans and prospects for Xeris Biopharma Holdings, Inc., including
the potential benefits of its novel SC formulation of
levothyroxine, its ability to recruit additional clinical trial
subjects, the anticipated completion date of the Phase 2
dose-finding study of XP-8121, the market and therapeutic potential
of its products and product candidates, the potential utility of
its formulation platforms, and other statements containing the
words “will,” “would,” “continue,” “expect,” “anticipate” 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,
geopolitical factors 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. The various factors
that 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, include its financial position and need
for financing, including to fund its product development programs
or commercialization efforts, whether its products will achieve and
maintain market acceptance in a competitive business environment,
its reliance on third-party suppliers, including single-source
suppliers, its reliance on third parties to conduct clinical
trials, the ability of its product candidates to compete
successfully with existing and new drugs, and its and
collaborators’ ability to protect its intellectual property and
proprietary technology. No assurance can be given that such
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
potential impacts of COVID-19, financial, operational, economic,
competitive, regulatory, governmental, technological, and other
factors that may affect Xeris can be found in Xeris’ filings,
including its most recently filed Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission, the contents of
which are not incorporated by reference into, nor do they form part
of, this communication. Forward-looking statements in this
communication are based on information available to us, 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, we do 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/20230621688257/en/
Allison Wey Senior Vice President, Investor Relations and
Corporate Communications awey@xerispharma.com 312-736-1237
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