Astria Therapeutics Presents New Preclinical Data Showing Differentiated Profile of STAR-0215, in Development for Treatment of Hereditary Angioedema

Rhea-AI Summary

Astria Therapeutics (NASDAQ: ATXS) presented new preclinical data showing that STAR-0215 effectively inhibits plasma kallikrein in cynomolgus monkeys, supporting potential dosing once every three months. This was discussed at the European Academy of Allergy and Immunology 2022 Congress in Prague. The study demonstrated rapid inhibition and prolonged pharmacological activity, with expectations to begin a Phase 1a clinical trial in healthy volunteers this year. The goal is to develop a patient-friendly treatment for hereditary angioedema (HAE).

Positive

• STAR-0215 shows rapid and sustained inhibition of plasma kallikrein.
• Potential for dosing once every three months, enhancing patient convenience.
• Positive preclinical results support advancement to Phase 1a clinical trial.

Negative

• None.

-- Results Continue to Support that STAR-0215 is a Potent, Selective, and Long-Acting Monoclonal Antibody Inhibitor of Plasma Kallikrein --

-- STAR-0215 Demonstrates Rapid and Sustained Inhibition of Plasma Kallikrein After Subcutaneous Administration in Monkeys --

BOSTON--(BUSINESS WIRE)-- Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for hereditary angioedema and focused on life-changing therapies for rare and niche allergic and immunological diseases, presented new preclinical data that demonstrate STAR-0215’s rapid and durable inhibition of plasma kallikrein in cynomolgus monkeys, supporting the potential for once every three month or longer dosing in humans. The Flash Talks session entitled “STAR-0215, a Long-Acting Monoclonal Antibody Plasma Kallikrein Inhibitor in Development for Treatment of HAE, Demonstrated Sustained Functional Inhibition in Subcutaneously Dosed Cynomolgus Monkeys” was presented at the European Academy of Allergy and Immunology 2022 Hybrid Congress in Prague, Czech Republic.

“These new preclinical results continue to support that STAR-0215 is a novel, potent, and selective inhibitor of plasma kallikrein, and demonstrate the potential for STAR-0215 to be dosed once every 3 months or longer,” said Andy Nichols, Ph.D., Chief Scientific Officer at Astria Therapeutics. “We expect to advance STAR-0215 into the clinic this year with our Phase 1a trial in healthy volunteers, which would bring us another step closer to our goal of developing the most patient-friendly treatment for HAE.”

The study, conducted in cynomolgus monkeys, showed rapid inhibition of plasma kallikrein after subcutaneous administration. Inhibition of HMWK cleavage was rapid and sustained throughout an 84-day dose-free period in the extended portion of the study. These data confirm the long half-life of STAR-0215 and demonstrate prolonged pharmacological activity of STAR-0215 in circulation in cynomolgus monkeys.

STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein designed to provide long-acting, effective attack prevention for HAE with dosing once every 3 months or longer. The company’s goal is to provide the most patient-friendly preventative treatment option for people living with HAE.

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 expected commencement of a Phase 1a clinical trial for STAR-0215; the potential attributes and differentiated profile of STAR-0215 as a treatment for HAE; and the Company’s broader 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: related to 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 with respect to STAR-0215 in HAE or with respect to any other future product candidates; the anticipated position and attributes of STAR-0215 in HAE based on its pre-clinical profile, pharmacokinetic modeling and other data; 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

Source: Astria Therapeutics, Inc.

FAQ

What are the recent findings regarding STAR-0215 by Astria Therapeutics?

Recent findings indicate that STAR-0215 effectively inhibits plasma kallikrein in cynomolgus monkeys, supporting its potential as a long-acting treatment for hereditary angioedema.

When is the Phase 1a clinical trial for STAR-0215 expected to start?

The Phase 1a clinical trial for STAR-0215 is expected to commence this year.

What is the significance of the dosing schedule for STAR-0215?

The dosing schedule of once every three months or longer for STAR-0215 could provide a more patient-friendly treatment option for hereditary angioedema.

Where was the new data on STAR-0215 presented?

The new data on STAR-0215 was presented at the European Academy of Allergy and Immunology 2022 Congress in Prague.

What is STAR-0215 designed to treat?

STAR-0215 is designed to treat hereditary angioedema (HAE) by inhibiting plasma kallikrein.