-- Trial Designed to Demonstrate Efficacy and
Safety of Every 3- and Every 6-Month Administration in a 6-Month
Treatment Period --
Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical
company focused on developing life-changing therapies for allergic
and immunologic diseases, today announced the initiation of the
ALPHA-ORBIT Phase 3 clinical trial of navenibart in people living
with hereditary angioedema (HAE). Navenibart has the potential to
provide rapid and sustained HAE attack prevention with a very low
treatment burden and administration every 3 months (Q3M) and every
6 months (Q6M).
“We believe that navenibart will deliver strong efficacy, low
treatment burden, and favorable safety and tolerability and we are
thrilled to have initiated our Phase 3 ALPHA-ORBIT trial to support
that vision,” said Christopher Morabito, M.D., Chief Medical
Officer at Astria Therapeutics. “The Phase 3 program is designed to
enable options, providing patients and physicians with the
potential to decide what works best for them by administering
navenibart only 2 or 4 times per year.”
“We understand from patients that it would be incredibly
meaningful to have a therapy that would enable them to live their
lives free from the limitations of HAE,” said Dr. Aleena Banerji,
Clinical Director MGH Allergy and Immunology Unit, and a Principal
Investigator for the ALPHA-ORBIT trial. “Navenibart has
demonstrated the potential to prevent HAE attacks with infrequent
dosing, which could allow patients the freedom to spend less time
managing their disease.”
ALPHA-ORBIT is a global, randomized, double-blind,
placebo-controlled Phase 3 pivotal clinical trial to evaluate the
efficacy and safety of navenibart over a 6-month treatment period
in up to 135 adults and 10 adolescents (open label), with HAE Type
1 or Type 2. Adult patients will be randomized to receive one of
three navenibart dose arms: 1) an initial 600 mg dose followed by
300 mg Q3M, 2) 600 mg Q6M, 3) 600 mg Q3M, or placebo; adolescents
will receive an initial 600 mg dose followed by 300 mg Q3M. The
dose arms support the potential to provide patient-centered dosing
flexibility to people with HAE. The primary endpoint is
time-normalized monthly HAE attacks at 6 months, and a key
secondary endpoint includes the proportion of participants who are
attack-free at 6 months. Top-line results from the trial are
anticipated in early 2027.
For more information on the ALPHA-ORBIT Phase 3 trial, please
visit AlphaOrbit.longboat.com, astriatrials.com, or
clinicaltrials.gov, NCT06842823.
After 6 months, patients may be eligible to enter a long-term
trial, called ORBIT-EXPANSE, in which all patients will be treated
with navenibart and which includes a patient-centered flexible
dosing period. The navenibart Phase 3 program consists of the
ALPHA-ORBIT Phase 3 trial and ORBIT-EXPANSE long-term trial, which
are designed to support registration globally.
The Phase 3 program was designed based on positive final
top-line results from target enrollment in the Phase 1b/2
ALPHA-STAR trial of navenibart, which showed rapid onset of robust
and durable efficacy, favorable safety and tolerability, and
pharmacokinetics and pharmacodynamics consistent with sustained
plasma kallikrein inhibition for both Q3M and Q6M administration.
Final results included reduction in mean monthly attack rate of
90-95% and up to a 67% attack-free rate over 6 months.
About Navenibart:
Navenibart is an investigational monoclonal antibody inhibitor
of plasma kallikrein in Phase 3 development for the treatment of
HAE. Our goal with navenibart is to provide rapid and sustained HAE
attack prevention with a validated mechanism and trusted modality
administered every 3 and 6 months. We aim to empower people with
HAE to live without limitations from their disease.
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: our
expectations about the potential significance of the topline
results from the target enrollment of the Phase 1b/2 ALPHA-STAR
clinical trial of navenibart, including with respect to the
selection of the dosing for the Phase 3 program; the expected
timing of receipt of topline results from the ALPHA-ORBIT trial;
the goals of the design of the navenibart Phase 3 program; our goal
of developing two dosing options for navenibart and the potential
advantages and benefits thereof; the potential for navenibart in
the HAE market, including the potential to be the market leading
treatment in HAE, the potential therapeutic and other benefits of
navenibart as a treatment for HAE, and our vision and goals for the
program; and the goal of bringing life changing therapies to
patients and families affected by allergic and immunological
diseases and to become a leading allergy and immunology company.
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 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 and clinical results
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 the following risks and uncertainties: 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, including of navenibart and STAR-0310, may not
be replicated in clinical trials, that the preliminary 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 navenibart Phase 1a clinical trial and the
ALPHA-STAR trial, may not be replicated in later stage clinical
trials, including the navenibart Phase 3 program; 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 may not commence, continue or be completed on time, or at
all; decisions made by, and feedback received from, the FDA and
other regulatory authorities on our regulatory and clinical trial
submissions 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, and devices for such product
candidates; our ability to manufacture sufficient quantities of
drug substance and drug product for navenibart, STAR-0310, and any
other future product candidates, and devices for such product
candidates, on a cost-effective and timely basis, and to develop
dosages and formulation for navenibart, STAR-0310, and any other
future product candidates that are patient-friendly and
competitive; our ability to develop biomarker and other assays,
along with the testing protocols therefore; 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 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 with respect to the ability of
STAR-0310 to compete in AD and the anticipated position and
attributes of STAR-0310 in atopic dermatitis based on its
preclinical profile; 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/20250227320197/en/
Astria Contact: Investor
Relations and Media: Elizabeth Higgins
investors@astriatx.com
Astria Therapeutics (NASDAQ:ATXS)
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