-- Differentiated Preclinical Lead Candidate
STAR-0310 to be Developed as a Potential Best-in-Class Long-Acting
Treatment for Atopic Dermatitis –
-- Conference Call and Webcast to be Held on
October 12, 2023 at 8:30am ET --
Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical
company focused on developing life-changing therapies for allergic
and immunological diseases, today announced that it has entered
into a worldwide exclusive license agreement with Ichnos Sciences
for an OX40 portfolio to be developed for the potential treatment
of atopic dermatitis (AD) and potentially for other allergic and
immunological diseases. Astria plans to develop the lead candidate,
called STAR-0310, a monoclonal antibody OX40 antagonist that
incorporates YTE half-life extension technology, for the treatment
of AD. Astria believes STAR-0310, a preclinical-stage program, has
the potential to have the best-in-class profile in AD with high
affinity, reduced treatment burden with infrequent dosing, and
favorably differentiated safety and tolerability. OX40 inhibition
is a clinically validated mechanism for the treatment of AD. Astria
also sees an opportunity with STAR-0310 for potential expansion
into additional indications.
“We are very proud to add such a strong program to our company
that supports our vision of strategic growth for the future,” said
Jill C. Milne, Ph.D., Chief Executive Officer at Astria
Therapeutics. “We are building a pipeline of potential first-choice
products that can improve the health and outcomes for allergy and
immunology patients. We believe STAR-0310 is a perfect complement
to STAR-0215. The initial results from the Phase 1a trial support
investigating STAR-0215 in hereditary angioedema (HAE) patients and
also suggest that there could be an opportunity to dose STAR-0215
every three or six months. Additionally, the Phase 1b/2 trial in
HAE patients is on-track and enrolling the third and final cohort,
with initial proof-of-concept results expected mid-2024. We expect
to initiate a pivotal Phase 3 trial in Q1 2025, assuming positive
Phase 1b/2 results. We believe our pipeline has the potential to
deliver significant benefit to patients with validated mechanisms
and potential best-in-class profiles.”
“Our team worked hard to find a product that was the right fit
for Astria’s mission, vision, goals, and plans for the future, and
we believe we have found such a program with STAR-0310,” said
Andrea Matthews, Chief Business Officer at Astria Therapeutics.
“With our team’s expertise in antibody development, our
understanding of the market, and our commitment to improving
outcomes for patients, we are confident that we can become a leader
in the development of first-choice allergy and immunology
therapies.”
Ichnos Sciences developed a portfolio of monoclonal antibody
antagonists of OX40, including STAR-0310 and telazorlimab, which
Astria has exclusively in-licensed worldwide in all fields.
STAR-0310 was developed by applying YTE half-life extension
technology to an affinity-matured version of telazorlimab. By
targeting OX40, STAR-0310 is designed to address a wide range of T
cells involved in the heterogenous AD pathology, providing the
potential for better efficacy and a broader addressable patient
population. In addition, STAR-0310 has been engineered to minimize
T cell depletion. As a potential long-acting OX40 inhibitor,
STAR-0310 aims to address the need for a safe, effective, and
infrequently administered AD treatment.
Astria expects to submit an Investigational New Drug (IND)
application for STAR-0310 by year-end 2024 and, if the IND is
cleared, plans to initiate a Phase 1a clinical trial in healthy
subjects in the first quarter of 2025. Astria anticipates reporting
initial results from the trial in the third quarter of 2025. Astria
anticipates these initial results will be an important milestone
for the program and that these initial results have the potential
to establish early proof of concept of STAR-0310, including
potentially demonstrating long half-life, initial PD, and safety
and tolerability. Pending positive results from the Phase 1a
clinical trial, Astria plans to initiate a Phase 1b clinical trial
in patients with AD shortly thereafter, with initial results
anticipated in second quarter of 2026, the goals of which are to
demonstrate proof of concept of STAR-0310, initial efficacy in AD
as well as show differentiation on safety and tolerability. Based
on the inclusion of the YTE modification, Astria believes STAR-0310
has the potential to be dosed once every two to three months.
About the License:
Under the terms of the license agreement, Astria will pay Ichnos
a one-time upfront license fee of $15 million. Astria is also
obligated to pay Ichnos up to $305 million in milestones, of which
up to $20 million are clinical development milestones in up to
three indications and $285 million are related to regulatory
approval and commercial sales milestones for all licensed products
in up to three indications. In addition, Ichnos will be eligible to
receive tiered mid-single digit to low-double digit royalties based
on Astria’s and any of its affiliates’ or sublicensees’ annual net
sales of the licensed products, subject to reduction in specified
circumstances.
Webcast Information:
Astria Therapeutics will host a live webcast and conference call
on October 12, 2023, at 8:30am ET to discuss the OX40 program
STAR-0310. Interested parties may join the webcast via the
Investors section of the Astria website, www.astriatx.com, or with
the following link: https://lifescievents.com/event/astria/
Please connect to the webcast several minutes prior to the start
of the broadcast to ensure adequate time for any software download
that may be required. The webcast will be archived for 90 days.
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 immunological diseases. Our lead
program, STAR-0215, is a monoclonal antibody inhibitor of plasma
kallikrein in clinical development for the treatment of hereditary
angioedema. STAR-0310 is a monoclonal antibody OX40 antagonist in
preclinical development for the treatment of atopic dermatitis.
Learn more about our company on our website, www.astriatx.com, or
follow us on Twitter and Instagram @AstriaTx and on Facebook and
LinkedIn.
Cautionary Note Regarding 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 regarding adding additional cohorts, and the timing of
the results therefrom, to our Phase 1a clinical trial of STAR-0215,
and the timing of availability of final results from such trial;
our expectations regarding the potential significance of the
preliminary results from the Phase 1a STAR-0215 clinical trial and
the anticipated nature and timing of receipt of additional data
from such trial; our expectations regarding the timing, nature,
goals and results of our Phase 1b/2 clinical trial of STAR-0215 and
that favorable results from such trial could allow us to move
directly into a Phase 3 pivotal trial of STAR-0215 as a potential
treatment for HAE; our expectations about the design and
anticipated timing of a Phase 3 pivotal clinical trial for
STAR-0215 as a potential treatment for HAE, assuming positive data
from the Phase 1b/2 trial; the potential therapeutic benefits and
potential attributes of STAR-0310 as a treatment for atopic
dermatitis, or AD; expectations regarding the timing of regulatory
filings for STAR-0310; expectations regarding the timing of
initiation and planned design of clinical trials for STAR-0310; the
expectations regarding the timing and nature of anticipated data
for planned trials of STAR-0310; our goals and vision for
STAR-0310; the potential commercial opportunity for STAR-0310 in AD
and the likelihood that it can effectively compete in AD, assuming
it is approved; the size of the AD market and the need for
treatments for AD and the goal to meet the unmet needs of patients
with rare and niche allergic and immunological 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
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 the 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: changes in applicable
laws or regulations; the possibility that we may be adversely
affected by other economic, business, and/or competitive factors,
including the COVID-19 pandemic; 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 results from clinical
trials, including the Phase 1a clinical trial may not be indicative
of the final results, that the results of early stage clinical
trials, such as the preliminary results from the Phase 1a clinical
trial, may not be replicated in later stage clinical trials,
including the ALPHA-STAR 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 may not
commence, continue or be completed on time, or at all; decisions
made by, and feedback received from, the U.S. Food and Drug
Administration 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 STAR-0215,
STAR-0310, and any other future development candidates; our ability
to manufacture sufficient quantities of drug substance and drug
product for STAR-0215, STAR-0310, and any other future product
candidates on a cost-effective and timely basis, and to develop
dosages and formulation for STAR-0215, 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 STAR-0215,
STAR-0310, and any other future product candidates; our potential
dependence on collaboration partners; competition with respect to
STAR-0215, 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
hereditary angioedema (HAE), the ability of STAR-0215 to compete in
HAE and the anticipated position and attributes of STAR-0215 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; risks with respect to the ability of STAR-0310 to compete
in AD and the anticipated position and attributes of STAR-0310 in
AD 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, 2022 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/20231011280502/en/
Investor Relations and Media: Elizabeth Higgins
investors@astriatx.com
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