-- Early Proof-of-Concept Results from the
Phase 1a Trial Anticipated in Q3 2025 --
Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical
company focused on developing life-changing therapies for allergic
and immunologic diseases, today announced initiation of a Phase 1a
clinical trial of STAR-0310 in healthy subjects. STAR-0310, a high
affinity monoclonal antibody OX40 antagonist that incorporates YTE
technology, is in development for the potential treatment of atopic
dermatitis (AD) and potentially other indications. The Phase 1a
trial is intended to assess the safety, tolerability,
pharmacokinetics, and immunogenicity of STAR-0310 in healthy adult
participants. Astria expects early proof-of-concept results from
the Phase 1a trial in the third quarter of 2025.
“The Phase 1a trial of STAR-0310 in healthy subjects is an
important opportunity for us to clinically differentiate the
profile of STAR-0310,” said Jill C. Milne, Ph.D., Chief Executive
Officer at Astria Therapeutics. “We believe STAR-0310 will be the
best-in-class therapy due to efficacy, safety and tolerability, and
treatment burden, and could transform lives for many people living
with moderate-to-severe AD.”
The Phase 1a randomized, double-blind, placebo-controlled single
ascending dose trial is evaluating the safety, tolerability,
pharmacokinetics, and immunogenicity of STAR-0310 in approximately
40 healthy adult participants.
Preclinical results support the potential for STAR-0310 to have
the best-in-class OX40 inhibitor profile. By design, there is
significantly less antibody-dependent cellular cytotoxicity (ADCC)
with STAR-0310 compared to rocatinlimab, an OX40 antagonist
currently in Phase 3 development for the treatment of AD. Reduction
in ADCC activity has the potential for a more favorable safety
profile and potentially wider therapeutic window for STAR-0310,
which we believe provides the potential to drive more efficacy.
STAR-0310 exhibits a long mean half-life of 26 days in cynomolgus
monkeys, compared to 10-14 days in a typical non-half-life extended
IgG1 antibody, and has comparable potency to rocatinlimab.
About Astria Therapeutics:
Astria Therapeutics is a biopharmaceutical company, and our
mission is to bring life-changing therapies to patients and
families affected by allergic and immunologic diseases. Our lead
program, navenibart (STAR-0215), is a monoclonal antibody inhibitor
of plasma kallikrein in clinical development for the treatment of
hereditary angioedema. Our second program, STAR-0310, is a
monoclonal antibody OX40 antagonist in clinical development for the
treatment of atopic dermatitis. Learn more about our company on our
website, www.astriatx.com, or follow us on Instagram @AstriaTx and
on Facebook and LinkedIn.
Forward Looking Statements:
This press release contains forward-looking statements within
the meaning of applicable securities laws and regulations
including, but not limited to, statements regarding: the expected
timing of receipt of early proof of concept results from STAR-0310
Phase 1a trial; the aims and objectives of the STAR-0310 Phase 1a
trial; the development of STAR-0310 as a potential treatment for AD
and potentially other indications; the potential therapeutic
benefits of STAR-0310 as a treatment for AD, including its
potential best-in-class profile and the potential attributes of
STAR-0310 that would give it such a profile; and our corporate
strategy and vision, including our mission to bring life-changing
therapies to patients and families affected by allergic and
immunologic diseases. The use of words such as, but not limited to,
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“goals,” “intend,” “may,” “might,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will,” “would,” or "vision," and
similar words and expressions are intended to identify
forward-looking statements. Forward-looking statements are neither
historical facts nor assurances of future performance. Instead,
they are based on Astria’s current beliefs, expectations and
assumptions regarding the future of its business, future plans and
strategies, future financial performance, results of pre-clinical
studies and clinical trials of Astria’s product candidates and
other future conditions. Actual results may differ materially from
those indicated by such forward-looking statements as a result of
various important factors, including risks and uncertainties
related to: changes in applicable laws or regulations; the
possibility that we may be adversely affected by other economic,
business, and/or competitive factors; risks inherent in
pharmaceutical research and development, such as: adverse results
in our drug discovery, preclinical and clinical development
activities, the risk that the results of preclinical studies may
not be replicated in clinical trials, that the preliminary, initial
or interim results from clinical trials may not be indicative of
the final results, that the results of early stage clinical trials,
such as the results from the ALPHA-STAR Phase 1b/2 clinical trial,
may not be replicated in later stage clinical trials, such as the
ALPHA-ORBIT trial and the open-label extension trial, the risk that
we may not be able to enroll sufficient patients in our clinical
trials on a timely basis, and the risk that any of our clinical
trials, including ALPHA-ORBIT, may not commence, continue or be
completed on our anticipated timelines, or at all; decisions made
by, and feedback received from, the FDA and other regulatory
authorities on our clinical trial design, including for
ALPHA-ORBIT, and on our regulatory and clinical trial submissions,
including receipt of FDA minutes from our December 2024 end of
Phase 2 meeting, and other feedback from potential clinical trial
sites, including investigational review boards at such sites, and
other review bodies with respect to navenibart, STAR-0310, and any
other future development candidates, decisions that we make about
the design of clinical trials in response to regulatory feedback,
including the design of the ALPHA-ORBIT trial and the long-term
extension trial; our ability to manufacture sufficient quantities
of drug substance and drug product for navenibart, STAR-0310, and
any other future product candidates on a cost-effective and timely
basis, and to develop dosages and formulations for navenibart,
STAR-0310, and any other future product candidates that are
patient-friendly and competitive; our ability to develop sufficient
data to enable the use of planned devices with navenibart,
STAR-0310 and any other future product candidates at commercial
launch or otherwise as planned; our ability to develop biomarker
and other assays, along with the testing protocols therefor; our
ability to obtain, maintain and enforce intellectual property
rights for navenibart, STAR-0310 and any other future product
candidates; our potential dependence on collaboration partners;
competition with respect to navenibart, STAR-0310, or any of our
other future product candidates; the risk that survey results,
modeling data and market research may not be accurate predictors of
the commercial landscape for HAE, the ability of navenibart to
compete in HAE and the anticipated position and attributes of
navenibart in HAE based on clinical data to date, its preclinical
profile, pharmacokinetic modeling, market research and other data;
risks that any of our clinical trials of STAR-0310 may not
commence, continue or be completed on time, or at all; risks that
results of preclinical studies of STAR-0310 will not be replicated
in clinical trials; our ability to manage our cash usage and the
possibility of unexpected cash expenditures; our ability to obtain
necessary financing to conduct our planned activities and to manage
unplanned cash requirements; the risks and uncertainties related to
our ability to recognize the benefits of any additional
acquisitions, licenses or similar transactions; and general
economic and market conditions; as well as the risks and
uncertainties discussed in the “Risk Factors” section of our Annual
Report on Form 10-K for the period ended December 31, 2023 and in
other filings that we may make with the Securities and Exchange
Commission. New risks and uncertainties may emerge from time to
time, and it is not possible to predict all risks and
uncertainties. Astria may not actually achieve the forecasts or
expectations disclosed in our forward-looking statements, and
investors and potential investors should not place undue reliance
on Astria’s forward-looking statements.
Neither Astria, nor its affiliates, advisors or representatives,
undertake any obligation to publicly update or revise any
forward-looking statement, whether as result of new information,
future events or otherwise, except as required by law. These
forward-looking statements should not be relied upon as
representing Astria’s views as of any date subsequent to the date
hereof.
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version on businesswire.com: https://www.businesswire.com/news/home/20250123072294/en/
Astria Contact: Investor
Relations and Media: Elizabeth Higgins
investors@astriatx.com
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