BOSTON, Mass.– Astria Therapeutics, Inc. (NASDAQ: ATXS), a biopharmaceutical company 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 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 Phase 3 navenibart program includes two key studies—ALPHA-ORBIT and ORBIT-EXPANSE—designed to support global registration. Participants who complete the ALPHA-ORBIT trial may continue into ORBIT-EXPANSE, where all will receive navenibart in one of two dosing regimens: every three months (Q3M) or every six months (Q6M).
The ORBIT-EXPANSE trial features two parts. In Part 1, participants will receive a fixed dosing regimen for at least six months. In Part 2, patients may transition between regimens based on individual needs during a flexible dosing period, emphasizing Astria’s patient-centered approach to treatment.
The initiation of ORBIT-EXPANSE represents another milestone in Astria’s mission to deliver long-term, effective, and patient-tailored therapies for individuals living with hereditary angioedema worldwide.
