Astria Therapeutics Announces Publication of STAR-0215 Preclinical Data in the Journal of Pharmacology and Experimental Therapeutics
31 Agosto 2023 - 9:00AM
Business Wire
Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical
company developing STAR-0215 for the treatment of hereditary
angioedema (HAE) and focused on life-changing therapies for rare
and niche allergic and immunological diseases, today announced that
preclinical data supporting STAR-0215’s profile as a potential
long-acting therapy for hereditary angioedema (HAE) dosed once
every three or six months has been published in the Journal of
Pharmacology and Experimental Therapeutics.
“We were very pleased by our publication in the Journal of
Pharmacology and Experimental Therapeutics, further validating the
exciting science behind STAR-0215,” said Jill C. Milne, Ph.D.,
Chief Executive Officer at Astria Therapeutics. “These results
demonstrate that STAR-0215 is a potential best-in-class plasma
kallikrein inhibitor as it shows high potency in vitro and in vivo
and long half-life, suggesting potential for sustained, durable HAE
attack suppression with subcutaneous administration.”
Overview of STAR-0215 Preclinical Results:
- STAR-0215’s YTE modification in the Fc domain enhances FcRn
receptor binding, resulting in a ~3-fold prolonged half-life in
cynomolgus monkeys compared to antibodies without this
modification.
- STAR-0215 has a >1000-fold lower affinity for prekallikrein
and no measurable inhibitory activity against other serine
proteases, demonstrating potent and specific binding for STAR-0215
for human plasma kallikrein.
- STAR-0215 demonstrated potent in vitro inhibition of plasma
kallikrein-mediated bradykinin release from high molecular weight
kininogen (HWMK) in a physiologically relevant assay.
- STAR-0215 achieved inhibition of cleaved HMWK (cHMWK) in
cynomolgus monkeys within one day after dosing. This inhibition was
sustained throughout the duration of the study, including an 84-day
dose-free period, demonstrating both rapid and long-lasting
inhibition of plasma kallikrein achievable by subcutaneous
administration.
The publication can be found at the following link:
https://doi.org/10.1124/jpet.123.001740
STAR-0215 is a monoclonal antibody inhibitor of plasma
kallikrein in development for the treatment of HAE. Initial results
from a Phase 1a trial in healthy subjects support STAR-0215’s
target profile: a long-acting preventative therapy, best-in-class
pharmacokinetic (PK) profile, and dosing once every three or six
months. Final results from these three cohorts, as well as initial
results from two additional cohorts, are anticipated in the fourth
quarter of 2023. The Phase 1b/2 ALPHA-STAR trial evaluating
STAR-0215 in people living with HAE is ongoing, with initial
proof-of-concept results from single and multiple dose cohorts
expected in mid-2024.
About Astria Therapeutics:
Astria Therapeutics is a biopharmaceutical company, and our
mission is to bring life-changing therapies to patients and
families affected by rare and niche 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. Learn more about our company on
our website, www.astriatx.com, or follow us on Twitter and
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: expectations
regarding the timing and nature of additional results from the
ongoing STAR-0215 Phase 1a clinical trial; the timing and nature of
the anticipated proof of concept results from the ALPHA-STAR Phase
1b/2 clinical trial; the potential attributes and differentiated
profile of STAR-0215 as a treatment for HAE, and our vision for
STAR-0215 as a treatment for HAE; the need for effective treatments
for HAE; the potential for three and six-month administration of
STAR-0215; and our 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,” or “would” 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 the
Company’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 Company’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 pre-clinical studies may not be replicated
in clinical studies, that the preliminary results from the Phase 1a
trial may not be indicative of the final results, that the results
of early stage clinical studies, such as the preliminary and
initial unblinded results from the Phase 1a trial, may not be
replicated in later stage clinical studies, 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 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
STAR-0215 and any other future development candidates; the risk
that we do not realize some or all of the potential benefits of
STAR-0215's Fast Track designation; our ability to manufacture
sufficient quantities of drug substance and drug product for
STAR-0215 and any other future product candidates on a
cost-effective and timely basis, and to develop dosages and
formulation for STAR-0215 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 and any other future product
candidates; our potential dependence on collaboration partners;
competition with respect to STAR-0215 or any of our other future
product candidates; the risk that the clinical results to date,
survey results and market research may not be accurate predictors
of the commercial landscape for HAE, the ability of STAR-0215 to
compete in HAE and the anticipated position and attributes of
STAR-0215 in HAE based on its clinical data to date, pre-clinical
profile, mechanistic and other modeling, market research, patient
feedback and other data; 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 make with the Securities and Exchange
Commission (“SEC”). New risks and uncertainties may emerge from
time to time, and it is not possible to predict all risks and
uncertainties. The Company 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 the Company’s forward-looking statements. Neither the Company,
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 the Company’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/20230831644051/en/
Investor Relations and Media: Elizabeth Higgins
investors@astriatx.com
Astria Therapeutics (NASDAQ:ATXS)
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