Astria Therapeutics Reveals ALPHA-ORBIT Phase 3 Trial Design for Navenibart in HAE

Astria Therapeutics, Inc., a biopharmaceutical company dedicated to developing transformative therapies for allergic and immunologic disorders, has unveiled the design for its upcoming ALPHA-ORBIT Phase 3 clinical trial. This pivotal study will investigate the drug navenibart in individuals suffering from hereditary angioedema (HAE), focusing on both three-month and six-month treatment intervals, with the primary analysis set for six months. Launch activities for the trial have already commenced globally, with initiation anticipated in the first quarter of 2025 and key results expected by early 2027.

Astria's CEO, Jill C. Milne, emphasized the strategic design of the Phase 3 trial, which has been informed by regulatory input and aims to achieve global registration for both dosing schedules. The company hopes that navenibart will emerge as the leading therapy choice for HAE, offering significant flexibility to patients and reducing treatment burdens while effectively minimizing attack rates.

The ALPHA-ORBIT study is structured as a global, randomized, double-blind, placebo-controlled clinical trial. It will assess the effectiveness and safety of navenibart over a six-month period in up to 145 patients with Type 1 or Type 2 HAE. Participants will be randomly assigned to one of three dosage groups: an initial 600 mg dose followed by 300 mg every three months, a 600 mg dose every six months, or a 600 mg dose every three months. There is also a placebo group. The study aims to provide dosing flexibility tailored to patients' needs. The primary evaluation metric is the time-normalized monthly HAE attack rate after six months, and a secondary focus will be the percentage of participants who remain attack-free over the same period.

Upon completion of the initial six-month trial, participants may have the opportunity to join a long-term extension study, where all will receive open-label navenibart treatment, including flexible dosing options. This phase of the study is designed to support global drug registration efforts. The trial's blueprint incorporates insights from the European Medicines Agency and the U.S. Food and Drug Administration, following a critical Phase 2 meeting in December 2024.

The dosing strategies selected for the ALPHA-ORBIT trial are based on successful outcomes from the Phase 1b/2 ALPHA-STAR trial, which demonstrated rapid and lasting efficacy, coupled with favorable safety profiles. The Phase 1b/2 trial results showed a dramatic reduction in the average monthly attack rate by 90-95% and an attack-free rate of up to 67% over six months. These findings will be presented at an upcoming scientific conference.


Astria Therapeutics, headquartered in Boston, is committed to offering life-changing solutions for patients and families dealing with allergic and immunologic conditions. Navenibart, their leading product in development, works by inhibiting plasma kallikrein to prevent HAE attacks. The company also has a pipeline candidate, STAR-0310, an OX40 antagonist for atopic dermatitis, currently in preclinical stages. Astria aims to empower people with HAE by significantly reducing the disease's impact on their lives.

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