New data on navenibart, a potential HAE medicine, published in the Annals of Allergy, Asthma & Immunology
The results from a Phase 1a trial of navenibart in healthy subjects have been published in the journal Annals of Allergy, Asthma & Immunology. The pharmaceutical company developing navenibart, Astria Therapeutics, announced that these data supported the medicine’s potential to provide long-acting, safe, and effective attack prevention for hereditary angioedema (HAE), with dosing every 3 and 6 months.
Christopher Morabito MD, Chief Medical Officer at Astria Therapeutics, said: “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. 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.”
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.
(Source: Astria)