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Astria Launches Phase 3 Trial of Navenibart for HAE

Astria's new trial builds on the success of ALPHA-ORBIT, offering HAE patients a potential long-term solution with navenibart.

There is a beautiful red flower to the plant and the background of the flower is dark.
There is a beautiful red flower to the plant and the background of the flower is dark.

Astria Launches Phase 3 Trial of Navenibart for HAE

Astria Therapeutics, Inc. (NASDAQ:ATXS) has launched the Phase 3 ORBIT-EXPANSE long-term trial of navenibart, a monoclonal antibody inhibitor of plasma kallikrein, for the treatment of hereditary angioedema (HAE). Participants who have completed the ALPHA-ORBIT study are eligible to join.

The ORBIT-EXPANSE trial, registered as NCT07204938, follows the successful completion of the pivotal Phase 3 ALPHA-ORBIT trial (NCT06842823). It consists of two parts: a fixed dosing regimen for at least 6 months, followed by a patient-centered flexible dosing period. Eligible participants from the ALPHA-ORBIT trial can continue into the ORBIT-EXPANSE trial, receiving navenibart in Q3M (every 3 months) or Q6M (every 6 months) regimens.

Navenibart targets plasma kallikrein, a key mediator in HAE attacks. Astria Therapeutics, a biopharmaceutical company focused on allergic and immunologic diseases, is developing this therapy to provide relief to people living with HAE. The currently enrolling ALPHA-ORBIT trial can be found on AlphaOrbit.longboat.com, AstriaTrials.com, or clinicaltrials.gov.

The ORBIT-EXPANSE long-term trial aims to evaluate the long-term safety and efficacy of navenibart in HAE patients. Eligible participants from the ALPHA-ORBIT trial are encouraged to continue their participation in this new phase. Astria Therapeutics continues its commitment to developing life-changing therapies for HAE patients.

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