Astria Therapeutics Receives Fast Track Designation for STAR-0215 for the Treatment of Hereditary Angioedema
20 Julho 2023 - 9:00AM
Business Wire
-- On Track for Proof-of-Concept Results in HAE
Patients in Mid-2024 --
-- Results To-Date Support STAR-0215
Administration Once Every Three or Six Months for Robust
Suppression of HAE Attacks --
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
the STAR-0215 development program has received Fast Track
designation from the U.S. Food and Drug Administration (FDA) for
the treatment of Hereditary Angioedema (HAE), a rare genetic
disorder that causes severe unpredictable attacks of swelling
throughout the body. STAR-0215 is currently being evaluated in the
ALPHA-STAR clinical trial in people with HAE, with initial
proof-of-concept results expected in mid-2024.
“Receiving Fast Track designation for STAR-0215 is an important
milestone that underscores the need for HAE therapies that can
normalize the lives of people living with HAE with dosing every
three or six months,” said Jill C. Milne, Ph.D., Chief Executive
Officer at Astria Therapeutics. “We look forward to more frequent
communication with the FDA as we work to reduce both the disease
and treatment burden for the HAE community.”
The FDA Fast Track process is designed to expedite the
development and review of therapies to treat serious or
life-threatening conditions and that demonstrate the potential to
address unmet needs. Companies that receive Fast Track designation
for a product candidate are able to submit New Drug Applications
(NDA) for such candidate on a rolling basis, potentially expediting
the FDA review process, and benefit from more frequent
communication with the FDA to discuss all aspects of clinical
development. In addition, drugs that receive Fast Track designation
may be eligible for a priority review if certain criteria are
met.
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.
About STAR-0215:
STAR-0215 is a monoclonal antibody inhibitor of plasma
kallikrein in development for the treatment of HAE. Our vision is
for STAR-0215 to be the first-choice preventative treatment for
people with HAE dosed once every three or six months and to make
substantial progress towards normalizing their lives. The Phase
1b/2 ALPHA-STAR trial evaluating STAR-0215 in HAE patients is
ongoing, with proof-of-concept results expected in mid-2024.
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 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; the potential
benefits of STAR-0215's receipt of Fast Track designation; 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230720596934/en/
Astria:
Investor Relations and Media: Elizabeth Higgins
investors@astriatx.com
Astria Therapeutics (NASDAQ:ATXS)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Astria Therapeutics (NASDAQ:ATXS)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024