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Astria Therapeutics to Present STAR-0215 Data at the 2022 American Academy of Allergy, Asthma and Immunology Annual Meeting

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Astria Therapeutics (NASDAQ:ATXS) announced it will present new preclinical data for its drug candidate STAR-0215 at the AAAAI Annual Scientific Meeting in Phoenix, Arizona, on February 28, 2022. STAR-0215 is a long-acting monoclonal antibody designed to treat hereditary angioedema (HAE) by inhibiting plasma kallikrein, with a dosing schedule of once every three months or longer. After filing an IND application mid-2022, Astria plans to initiate a Phase 1 trial with initial results expected by year-end.

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BOSTON--(BUSINESS WIRE)-- Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema (HAE), today announced that it will share new preclinical data for STAR-0215 in a presentation titled “STAR-0215 Is a Long-Acting Monoclonal Antibody Plasma Kallikrein Inhibitor in Development for Treatment of HAE” at the 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Scientific Meeting in Phoenix, Arizona.

The poster will be presented in-person by Pradeep Bista, Ph.D., Vice President, Discovery and Translational Science at Astria Therapeutics, on Monday, February 28, 2022 at 9:45am MST, and the e-poster will be available to all registrants through the AAAAI Virtual Poster Hall.

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. Astria expects to file an Investigational New Drug application for STAR-0215 in mid-year this year and plans to initiate a Phase 1 trial shortly thereafter with initial results anticipated by year-end.

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.

Astria Contacts:

Investor relations:

Andrea Matthews

investors@astriatx.com

Media:

Elizabeth Higgins

media@astriatx.com

Source: Astria Therapeutics, Inc.

FAQ

What is STAR-0215 developed by Astria Therapeutics (ATXS)?

STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein aimed at preventing attacks in patients with hereditary angioedema (HAE).

When will Astria Therapeutics present data on STAR-0215?

Astria Therapeutics will present preclinical data for STAR-0215 on February 28, 2022, at the AAAAI Annual Scientific Meeting in Phoenix, Arizona.

What are the dosing expectations for STAR-0215?

STAR-0215 is designed for long-term use, with dosing expected to be once every three months or longer.

When does Astria Therapeutics plan to file an IND for STAR-0215?

Astria Therapeutics expects to file an Investigational New Drug application for STAR-0215 in mid-2022.

When does Astria Therapeutics expect results from the Phase 1 trial of STAR-0215?

Initial results from the Phase 1 trial of STAR-0215 are anticipated by the end of 2022.

Astria Therapeutics, Inc.

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