BOSTON, Mass. — Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced the initiation of the Phase 3 ORBIT-EXPANSE long-term trial of navenibart in people living with hereditary angioedema (HAE).
“The initiation of ORBIT-EXPANSE marks exciting progress in the development of navenibart,” said Christopher Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “The entrance of eligible and interested participants into the ORBIT-EXPANSE long-term trial following the completion of the pivotal Phase 3 ALPHA-ORBIT trial highlights enthusiasm for navenibart, and we are deeply grateful to trial participants and site facilitators for their continued partnership.”
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 completing ALPHA-ORBIT, eligible participants may continue into the ORBIT-EXPANSE trial, in which all participants will receive navenibart in either Q3M or Q6M regimens. The trial has two parts: in Part 1, participants will receive navenibart in a fixed dosing regimen for at least 6 months and, in Part 2, participants may move from one regimen to another based on their needs via a patient-centered flexible dosing period.
For more information on the ORBIT-EXPANSE long-term trial, please visit clinicaltrials.gov, NCT07204938. To learn more about the currently enrolling Phase 3 ALPHA-ORBIT 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 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 an investigational 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.
Astria Investor Relations and Media Contact
Elizabeth Higgins