Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced that it has begun opening clinical trial sites in the European Union (EU) and may begin screening participants for the Phase 3 ALPHA-ORBIT trial of navenibart, an investigational monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of hereditary angioedema (HAE) with the potential for dosing every 3 and 6 months.
Astria is enrolling the ongoing ALPHA-ORBIT trial with clinical trial sites open and accepting HAE patients across the United States, Europe, United Kingdom, Canada, Hong Kong, South Africa, Japan, North Macedonia, and Israel. Approval for the ALPHA-ORBIT trial from the European Medicines Agency (EMA) sanctions the activation of an anticipated 32 sites in 10 EU countries: Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, and Spain.
"We're thrilled to be enrolling eligible participants in the EU for the Phase 3 ALPHA-ORBIT trial," said Christopher Morabito, M.D., Chief Medical Officer at Astria Therapeutics. "The excitement we're seeing from physicians and patients in the EU underscores navenibart's potential to change the way people live with HAE across the globe."
"Navenibart's profile is compelling for people living with HAE, and we are thrilled that HAE patients in Europe now have the opportunity to enroll in the ALPHA-ORBIT trial," said Danny Cohn, M.D., Ph.D., Head of the HAE Center of Expertise at Amsterdam UMC, Amsterdam, the Netherlands. "We encourage patients to work with their physician to learn more about the ALPHA-ORBIT trial and navenibart."
"People living with HAE are waiting; not just for treatments that reduce the burden of disease, but for those that also ease the burden of treatment," said Maria Kortekaas, President of HAE Netherlands, a non-profit organization. "Clinical trials are part of the promise of progress, and we are pleased that Astria has chosen to conduct this late-stage trial in numerous countries throughout Europe."
ALPHA-ORBIT is a global, randomized, double-blind, placebo-controlled Phase 3 pivotal clinical trial to evaluate the efficacy and safety of navenibart administered every 3 months or every 6 months in up to 135 adults and 10 adolescents with HAE Type 1 or Type 2. The primary endpoint is time-normalized monthly HAE attacks at 6 months, and a key secondary endpoint includes the proportion of participants who are attack-free at 6 months.
The navenibart Phase 3 program consists of the ALPHA-ORBIT Phase 3 trial and ORBIT-EXPANSE long-term trial, which are designed to support registration globally. After 6 months of participation in ALPHA-ORBIT, patients may be eligible to enter ORBIT-EXPANSE, in which all trial participants will be treated with navenibart and which includes a patient-centered flexible dosing period.
For more information on the ALPHA-ORBIT trial, please visit AlphaOrbit.longboat.com or https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en.
About Navenibart:
Navenibart is an investigational monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE. Our goal with navenibart is to provide rapid and sustained HAE attack prevention with a validated mechanism and trusted modality administered subcutaneously every 3 and 6 months. We aim to empower people living with HAE to live life without limitations from their disease.
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 immunologic diseases. Our lead program, navenibart (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 an investigational monoclonal antibody OX40 antagonist in clinical development for the treatment of atopic dermatitis. Learn more about our company on our website, www.astriatx.com, or follow us on 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 goals and objectives of the ALPHA-ORBIT trial; the potential of navenibart as a treatment for HAE and its profile; the need for additional HAE treatment options; and our corporate strategy and vision, including our mission is to bring life-changing therapies to patients and families affected by allergic and immunologic 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 related to: 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, initial 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 ALPHA-STAR Phase 1b/2 clinical trial and ALPHA-SOLAR clinical trial, may not be replicated in later stage clinical trials, such as ALPHA-ORBIT, 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 navenibart, STAR-0310, and any other future development candidates; our ability to manufacture sufficient quantities of drug substance and drug product for navenibart, STAR-0310, and any other future product candidates on a cost-effective and timely basis, and to develop dosages and formulations for navenibart, 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 therefor; our ability to obtain, maintain and enforce intellectual property rights for navenibart, STAR-0310 and any other future product candidates; our potential dependence on collaboration partners; competition with respect to navenibart, STAR-0310, or any of our other future product candidates; the risk that survey results, modeling data and market research may not be accurate predictors of the commercial landscape for HAE, the ability of navenibart to compete in HAE and the anticipated position and attributes of navenibart 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 of STAR-0310 may not commence, continue or be completed on time, or at all; risks that results of preclinical studies of STAR-0310 will not be replicated in clinical trials; 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, 2024 and in other filings that we may make with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the period ended June 30, 2025. 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.
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