Astria Therapeutics Announces Publication of Navenibart Phase 1a Healthy Subject Results in the Annals of Allergy, Asthma & Immunology
Astria Therapeutics, Inc., a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced that results from a Phase 1a trial in healthy subjects supporting navenibart’s potential to provide long-acting, safe, and effective attack prevention for hereditary angioedema (HAE) with dosing every 3 and 6 months have been published in the Annals of Allergy, Asthma & Immunology.
We are thrilled by our publication in the Annals of Allergy, Asthma & Immunology and the opportunity to provide additional information that affirms our belief in navenibart’s potential to become the first-choice therapy for HAE. The Phase 1a trial in healthy subjects laid the foundation for the advancement of navenibart and charted a path toward initiating ALPHA-ORBIT, our currently enrolling pivotal Phase 3 trial. The Phase 3 program, designed to introduce a potentially life-changing HAE therapy to eligible participants around the globe, is underway.
said Christopher Morabito, M.D., Chief Medical Officer at Astria Therapeutics.
Overview of results from the Phase 1a trial of navenibart in healthy subjects:
- For all doses ≥300 mg, navenibart mean half-life ranged from 82 to 105 days, supporting the potential for administration every 3 and 6 months. Navenibart’s inhibition of plasma kallikrein activity versus placebo was statistically significant (P<0.05).
- Navenibart was well-tolerated, with similar rates of adverse events between navenibart and placebo, and no serious adverse events were observed.
- Results demonstrated early proof of concept for navenibart as a potential long-acting therapy for HAE.
The publication can be found at the following link: https://doi.org/10.1016/j.anai.2025.03.016.
About Navenibart:
Navenibart is an investigational monoclonal antibody inhibitor of plasma kallikrein in Phase 3 development for the treatment of HAE. Our goal with navenibart is to provide rapid and sustained HAE attack prevention with a validated mechanism and trusted modality administered every 3 and 6 months. We aim to empower people with HAE to live without limitations from their disease.
For more information, read the original release.
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