BOSTON / Aug 12, 2024 / Business Wire / 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.