Astria Therapeutics, Inc. (NASDAQ:ATXS) announced on October 10, 2025 that it has initiated the Phase 3 ORBIT‑EXPANSE long‑term trial of its lead candidate navenibart for hereditary angioedema (HAE). The new study follows the completion of the pivotal ALPHA‑ORBIT Phase 3 trial and is designed to support global registration of navenibart.
The ORBIT‑EXPANSE trial enrolls participants who have completed ALPHA‑ORBIT and will receive navenibart in either a quarterly (Q3M) or semi‑annual (Q6M) dosing regimen. Part 1 of the study provides a fixed dosing period of at least six months, while Part 2 allows patients to transition between dosing schedules based on individual needs, offering a patient‑centered flexible dosing period.
Navenibart is a monoclonal antibody inhibitor of plasma kallikrein that delivers rapid and sustained HAE attack prevention with subcutaneous administration every three or six months. The trial, registered under NCT07204938, represents a critical operational milestone that expands the clinical data set needed for regulatory submissions and positions Astria to advance navenibart toward market approval.
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