Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunological diseases, today announced the initiation of the Phase 3 ORBIT-EXPANSE long-term study of navenibart in people with hereditary angioedema (HAE).
“The initiation of ORBIT-EXPANSE marks exciting progress in the development of navenibart,” said Christopher Morabito, MD, Chief Medical Officer at Astria Therapeutics. “The participation of eligible and interested participants in the long-term ORBIT-EXPANSE trial following the completion of the pivotal Phase 3 ALPHA-ORBIT trial underlines the enthusiasm for navenibart, and we are very grateful to the trial participants and the trial facilitators for their continued partnership.”
The navenibart Phase 3 program consists of the ALPHA-ORBIT Phase 3 study and the ORBIT-EXPANSE long-term study, which are designed to support enrollment worldwide. After completion of ALPHA-ORBIT, eligible participants can proceed to the ORBIT-EXPANSE study, in which all participants will receive navenibart in either the Q3M or Q6M regimen. The trial consists of two parts: in part 1, participants will receive navenibart on a fixed dosing schedule for a minimum of six months, and in part 2, participants can switch from one regimen to another based on their needs through a patient-centered flexible dosing period.
For more information about the long-term trial of ORBIT-EXPANSE, please visit clinicaltrials.gov NCT07204938. For more information about the currently ongoing ALPHA-ORBIT Phase 3 trial, please visit AlphaOrbit.longboat.com , AstriaTrials.com or clinicaltrials.gov NCT06842823.
About Navenibart:
Navenibart is a monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE. Our goal with navenibart is to provide rapid and sustainable HAE attack prevention with a validated mechanism and trusted modality administered subcutaneously every 3 and 6 months. We strive to enable people with HAE to live a life without limitations due to their disease.
About Astria Therapeutica:
Astria Therapeutics is a biopharmaceutical company and our mission is to provide life-changing therapies to patients and families affected by allergic and immunological diseases. Our lead program, navenibart (STAR-0215), is an investigational 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 clinical development for the treatment of atopic dermatitis. Read 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 and ORBIT-EXPANSE studies; the potential of navenibart as a treatment for HAE and its potential profile; and our business strategy and vision, including our mission, is to provide 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,” “could,” “plan,” “potential,” “predict,” “project,” “should,” “goal,” “will,” “would” or “vision” and similar expressions are intended to be forward-looking identify statements. Forward-looking statements are not historical facts or guarantees 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, preclinical and clinical results of Astria’s product candidates and other future circumstances. Actual results may differ materially from those indicated in such forward-looking statements as a result of various important factors, including risks and uncertainties associated with: 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 outcomes 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 of clinical trials may not be indicative of final results, that the results of early-stage clinical trials, such as the results of the ALPHA-STAR Phase 1b/2 clinical trial and The 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 in a timely manner, and the risk that any of our clinical trials may not commence, proceed 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 regarding our regulatory and clinical trial submissions and other feedback from potential clinical trial sites, including research committees at such sites, and other review authorities with respect to navenibart, STAR-0310 and other future development candidates; our ability to produce sufficient quantities of drug substances and drug products for navenibart, STAR-0310 and other future product candidates on a cost-effective and timely basis, and to develop dosages and formulations for navenibart, STAR-0310 and other future product candidates that are patient-friendly and competitive; our ability to develop biomarkers and other tests, along with testing protocols therefor; our ability to obtain, maintain and enforce intellectual property rights for navenibart, STAR-0310 and other future product candidates; our potential dependence on collaboration partners; competition related to navenibart, STAR-0310 or any of our other future product candidates; the risk that study results, modeling data and market research may not be accurate predictors of the commercial landscape for HAE, navenibart’s ability to compete in the HAE space and navenibart’s expected position and characteristics in HAE based on clinical data to date, preclinical profile, pharmacokinetic modeling, market research and other data; the risk that any of our clinical trials of STAR-0310 may not commence, proceed or be completed on time or at all; risks that results from preclinical studies with STAR-0310 will not be replicated in clinical trials; our ability to manage our cash usage and the possibility of unexpected cash expenses; our ability to obtain the necessary financing to conduct our planned operations and manage unplanned cash needs; the risks and uncertainties associated with 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 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 fully predict all risks and uncertainties. predict uncertainties. Astria may not actually achieve the predictions or expectations set forth 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 statements, whether as a 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 views of Astria as of any date subsequent to the date hereof.
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Contact person Astria:
Investor relations and media:
Elizabeth Higgins
investors@astriatx.com
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