Astria Therapeutics Initiates Phase 3 ORBIT-EXPANSE Trial Of Navenibart In Hereditary Angioedema

Astria Therapeutics, Inc., a biopharmaceutical company dedicated to developing transformative therapies for allergic and immunologic diseases, has announced the initiation of the Phase 3 ORBIT-EXPANSE long-term clinical trial evaluating navenibart in patients with hereditary angioedema (HAE). This marks another key milestone in Astria’s late-stage development program targeting improved quality of life for people living with 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 Phase 3 program for navenibart includes two global studies — ALPHA-ORBIT and ORBIT-EXPANSE, designed to collectively support registration across multiple regulatory jurisdictions. Following participation in ALPHA-ORBIT, eligible patients are invited to continue in the ORBIT-EXPANSE trial, where all participants receive navenibart administered in quarterly (Q3M) or biannual (Q6M) dosing regimens.

The ORBIT-EXPANSE study consists of two parts: during Part 1, participants will receive navenibart on a fixed dosing schedule for at least six months. In Part 2, the trial introduces a flexible dosing period, allowing patients to transition between regimens according to their clinical needs, thereby reinforcing Astria’s patient-centered approach in chronic disease management.