Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical
company focused on developing life-changing therapies for allergic
and immunological diseases, today announced that it has chosen
Ypsomed as its partner for the development of an autoinjector for
STAR-0215.
“With STAR-0215's profile, our goal is to develop a therapy that
allows patients to choose an approach that works best for their
lives with the option of infrequent three- and six-month
administration,” said John Ruesch, Senior Vice President,
Pharmaceutical Sciences and Technical Operations. “Our partnership
with Ypsomed, a leading developer and manufacturer of injection
systems, supports this goal through the planned development of an
autoinjector that enables our vision for STAR-0215 to be a therapy
that can effectively protect against HAE attacks while also having
a very low burden of treatment and administration.”
Assuming regulatory approval, Astria plans to launch STAR-0215
with both the Ypsomed YpsoMate autoinjector and a pre-filled
syringe, which would allow patients to choose the administration
regimen that would work best for their lives. Astria believes that
an autoinjector option is a great choice for STAR-0215 due to its
ease of use, needle shielding feature, and STAR-0215's proprietary
formulation that enables a quick injection with low risk of
pain.
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. Our second program, 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 X and Instagram @AstriaTx and on
Facebook and LinkedIn.
About YpsoMate:
The YpsoMate is a user-friendly two-step autoinjector. To
inject, the cap is removed and then the device is firmly pushed on
the patient’s skin. Visual and audible cues notify the patient of
the start and end of the injection, and the needle is covered
before and after the injection by a safety mechanism that protects
against needle-stick injuries and ensures that patients do not see
the needle. Furthermore, the autoinjector is based on Ypsomed’s
carbon footprint reduction NetZero Program, which reflects a
company-wide commitment to sustainability.
About Ypsomed AG:
Ypsomed is the leading developer and manufacturer of injection
and infusion systems for self-medication and a renowned diabetes
specialist. The company will celebrate its 40th anniversary in
2024. As a leader in innovation and technology, it is a preferred
partner of pharmaceutical and biotech companies for pens,
autoinjectors and pump systems for administering liquid
medications. Ypsomed presents and markets its product portfolios
under the umbrella brand mylife Diabetescare directly to patients,
pharmacies, and hospitals as well as under Ypsomed Delivery Systems
in business-to-business operations with pharmaceutical companies.
Ypsomed is headquartered in Burgdorf, Switzerland. The company has
a global network of production facilities, subsidiaries, and
distribution partners. Ypsomed has around 2,500 employees
worldwide.
For more information, please visit www.ypsomed.com.
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 plans to
launch STAR-0215 and the expected administration frequency; our
plans to launch STAR-0215 with both the Ypsomed YpsoMate
autoinjector and a pre-filled syringe, and the potential benefits
thereof; the potential for STAR-0215 to reduce the burden of
disease of HAE patients and certain other benefits of STAR-0215,
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. 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 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 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 STAR-0215 Phase 1a clinical trial and
initial results from the ALPHA-STAR trial may not be replicated in
later stage clinical trials, including the additional results from
the ALPHA-STAR trial and our planned Phase 3 program for STAR-0215
, 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 and devices that would administer STAR-0215, including
the Ypsomed YpsoMate autoinjector and pre-filled syringe; our
ability to manufacture sufficient quantities of drug substance,
drug product and devices for STAR-0215 on a cost-effective and
timely basis, and to develop dosages and formulation for STAR-0215
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; our potential dependence on
collaboration partners; competition with respect to STAR-0215; the
risk that 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 clinical data to date, its
preclinical profile, pharmacokinetic modeling, market research 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; 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/20240812920696/en/
Astria Contact: Investor
Relations and Media: Elizabeth Higgins
investors@astriatx.com
Astria Therapeutics (NASDAQ:ATXS)
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