BOSTON / Nov 10, 2023 / Business Wire / Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunological diseases, is presenting new STAR-0215 data in a poster presentation at the American College of Allergy, Asthma, and Immunology (ACAAI) in Anaheim, California that demonstrated STAR-0215’s profile as a potential HAE preventative therapy with robust attack suppression and low treatment burden in healthy adult subjects. These data confirm the potential for STAR-0215 to be dosed once every three months and every six months.

“These new data, including long-term follow-up from the original cohorts and initial data from new, higher dose cohorts, support our vision for STAR-0215 as a first-choice therapy for HAE. These data confirm our approach to administer STAR-0215 once every three and every six months in future trials. We intend to provide patients the option to choose what works best for their lives with a therapy that has a trusted modality and mechanism,” said Chris Morabito, M.D., Chief Medical Officer at Astria. “Our Phase 1b/2 ALPHA-STAR trial in HAE patients is on track and enrolling the third and final cohort. We now expect to deliver initial proof-of-concept data for STAR-0215 as a long-acting preventative therapy for HAE in Q1 2024. Patients from the ALPHA-STAR trial are enrolling in the long-term open label ALPHA-SOLAR trial to continue receiving STAR-0215, with data now accruing in patients who have received multiple doses of STAR-0215.”

In a poster titled, “Support for STAR-0215 Administered Every Three- or Six-Months for Hereditary Angioedema: Phase 1a Results,” Dr. William Lumry, M.D., Clinical Professor of Internal Medicine at the University of Texas Health Science Center at Dallas, is presenting clinical data including randomized, blinded, placebo-controlled, single ascending dose safety and tolerability data. STAR-0215 was well-tolerated, with no serious adverse events or discontinuations due to an adverse event, and low risk of injection pain. STAR-0215 achieved potentially therapeutic levels in less than one day and showed an estimated half-life of up to 127 days. Pharmacokinetic (PK) modeling of potential every three month and every six month clinical dose regimens over one to two years predict PK coverage believed to confer HAE attack prevention. Pharmacodynamic (PD) data showed statistically significant inhibition of plasma kallikrein for 140 to 224 days after single doses greater than 100 mg. These results demonstrate early proof-of-concept in healthy subjects for STAR-0215 as a potential HAE therapy with favorable safety profile, long half-life, and durable PD.

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 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 and 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 initial proof-of-concept results expected in the first quarter of 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: our expectations regarding the meaning and significance of the results from our STAR-0215 Phase 1a STAR-0215 clinical trial; our expectations regarding enrollment in the Phase 1b/2 ALPHA-STAR Trial and the timing of delivery of proof of concept data from such trial ; our vision for and the potential of STAR-0215 as a treatment for HAE, including expectations of dosing frequency, being a first choice preventative therapy and other potential attributes of STAR-0215; and the 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,” “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 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, may not be replicated in later stage clinical trials, including the ALPHA-STAR trial or the planned Phase 3 trial of 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, STAR-0310 and any other future development candidates; our ability to manufacture sufficient quantities of drug substance and drug product for STAR-0215, STAR-0310 and any other future product candidates on a cost-effective and timely basis, and to develop dosages and formulation for STAR-0215, STAR-0310 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, STAR-0310 and any other future product candidates; our potential dependence on collaboration partners; competition with respect to STAR-0215, STAR-0310 or any of our other future product candidates; 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; risks that any of our clinical trials may not commence, continue or be completed on time, or at all; 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 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.