Astria Therapeutics Presents New Preclinical Data Showing the Differentiated Profile of STAR-0215, in Development to Treat Hereditary Angioedema
05 November 2021 - 11:00PM
Business Wire
-- STAR-0215 Demonstrates High Potency to
Inhibit Plasma Kallikrein Preclinically --
-- Preclinical Data Show STAR-0215’s Extended
Plasma Half-Life, Predicting Long Duration of Action --
Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical
company developing STAR-0215 for the treatment of hereditary
angioedema (HAE), today presented new preclinical data that
included demonstration of the high potency of STAR-0215 to bind to
and inhibit plasma kallikrein on a site different than lanadelumab
and introduction of YTE technology to extend half-life. The poster
entitled “STAR-0215 is a Long-Acting Monoclonal Antibody Plasma
Kallikrein Inhibitor for the Potential Treatment of HAE” was
presented at the 2021 American College of Allergy, Asthma and
Immunology Annual Scientific Meeting in New Orleans, Louisiana.
“These preclinical data support the potential of STAR-0215 to
provide long-acting, effective prevention of HAE attacks, with
dosing once every three months or longer,” said Andy Nichols,
Ph.D., Chief Scientific Officer at Astria Therapeutics. “These data
show that STAR-0215 binds to plasma kallikrein with high affinity
and inhibits its activity more potently than lanadelumab, a plasma
kallikrein inhibitor on the market for the treatment of HAE.
Combined with the long plasma half-life from the YTE modifications
and high potency, we believe that STAR-0215 has a differentiated
profile that has the potential to be the most patient-friendly
preventative treatment option for HAE.”
HAE is a rare genetic disorder characterized by severe,
recurrent, unpredictable, painful, and sometimes life-threatening
swelling in the face, limbs, abdomen, and airway. Plasma kallikrein
binding affinity and plasma half-life are key drivers of efficacy
for the prevention of HAE attacks. The data presented today show
that STAR-0215 binds to plasma kallikrein in vitro with high
affinity, about ten-fold more potently than lanadelumab, a
monoclonal antibody plasma kallikrein inhibitor. In addition, in
competition binding experiments, STAR-0215 was shown to bind to a
different site on plasma kallikrein than lanadelumab. YTE
modifications in STAR-0215 are designed to enable a longer duration
of action. In cynomolgus monkeys dosed with STAR-0215, the enhanced
FcRn binding enabled by the YTE modifications translated to a more
than three-fold increase in plasma half-life to about 34 days with
STAR-0215 compared to an antibody without the YTE modifications.
The plasma half-life of STAR-0215 in cynomolgus monkeys was also
more than three-fold longer than that of lanadelumab, supporting
the potential for less frequent dosing.
STAR-0215’s potency was also tested using a physiologically
relevant assay. STAR-0215 potently inhibited the release of
bradykinin from high molecular weight kininogen, with an IC90 about
10-fold more potent than the IC90 achieved by lanadelumab in the
same assay. IC90 corresponds to the concentration required to
inhibit 90% of enzymatic activity, which is thought to be the level
of plasma kallikrein inhibition required to prevent HAE attacks.
Pharmacokinetic/pharmacodynamic modeling showed that STAR-0215 is
predicted to prevent HAE attacks for a substantially longer period
than lanadelumab. Based on these data, STAR-0215 has the potential
to be administered once every three months or longer to effectively
prevent HAE attacks.
STAR-0215 is in preclinical development to treat HAE, and is a
monoclonal antibody inhibitor of plasma kallikrein, designed to
provide long-acting, effective HAE attack prevention. The company’s
goal is to provide the most patient-friendly preventative treatment
option for people living with HAE. The company expects to file an
Investigational New Drug application for STAR-0215 in mid-2022 and
plans to initiate a Phase 1 clinical trial with initial results
anticipated by year end 2022.
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 preclinical 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: the Company’s expectations regarding the
timing for the filing of an IND and commencement of a Phase 1
clinical trial for STAR-0215, the timing of the initial results
from such trial; the potential attributes and differentiated
profile of STAR-0215 as a potential treatment for HAE; and the
Company’s mission to bring life changing therapies to patients and
families affected by 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 the Company 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, the Company’s ability to
enroll patients in our clinical trials, and the risk that any of
the Company’s clinical trials may not commence, continue or be
completed on time, or at all; decisions made by, or feedback
received from, the U.S. FDA and other regulatory authorities,
investigational review boards at clinical trial sites and other
review bodies with respect to STAR-0215 and any future product
candidates; the Company’s ability to manufacture sufficient
quantities of drug substance and drug product on a cost-effective
and timely basis; the Company’s ability to obtain, maintain and
enforce intellectual property rights for STAR-0215 and any other
future product candidates; competition; the Company’s ability to
manage its cash usage and the possibility of unexpected cash
expenditures; the Company’s ability to obtain necessary financing
to conduct its planned activities and to manage unplanned cash
requirements; general economic and market conditions; as well as
the risks and uncertainties set forth under the caption “Risk
Factors” in the Company’s most recent Annual Report on Form 10-K
filed with the SEC, as well as discussions of potential risks,
uncertainties, and other important factors in the Company’s
subsequent filings with the 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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Investor relations: Andrea Matthews
investors@astriatx.com
Media: Elizabeth Higgins media@astriatx.com
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