New data on navenibart, a potential HAE medicine currently being trialled, presented at key European Congress

Positive results drawn from two long-term, ongoing, clinical studies of navenibart to prevent HAE attacks, were presented at the recent 2025 European Academy of Allergy and Clinical Immunology Congress.

The data presented was one of four studies showcased at the EAACI Congress. These were:

  • Long-term Safety and Efficacy of Navenibart in Participants with Hereditary Angioedema (HAE): Initial Combined Results from ALPHA-STAR and ALPHA-SOLAR
  • Unveiling the Underlying Mechanism of Differentiation for STAR-0310, an Anti-OX40 Antibody for Atopic Dermatitis
  • Results from the ALPHA-STAR Trial, a Phase 1b/2 Single and Multiple Dose Study to Assess the Safety, Tolerability, Clinical Activity, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Navenibart in Participants with Hereditary Angioedema (HAE)
  • ALPHA-ORBIT: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants with Hereditary Angioedema (HAE)

Christopher Morabito MD, Chief Medical Officer at Astria Therapeutics, said: “We are thrilled to share positive initial results from the ALPHA-SOLAR long-term open-label trial. Results are consistent with navenibart’s best-in-class profile that we saw in the ALPHA-STAR Phase 1b/2 trial. With now 12 to 18 months on navenibart, these ALPHA-SOLAR results support navenibart’s favorable profile and the potential to administer navenibart every 3 and every 6 months. The Phase 3 ALPHA-ORBIT trial is evaluating both every 3- and every 6-month regimens and is actively enrolling patients.”

Dr William Yang MD PRCPC FAAAAI, Chair of the Ottawa Allergy Research Corporation and Red Maple Trials Inc, said: “The navenibart results in patients to date support the potential for patients to have long-acting protection from their HAE attacks with very low treatment burden. We are excited for the Phase 3 ALPHA-ORBIT trial and believe that navenibart’s profile with infrequent dosing could allow patients to spend less time thinking about their HAE, and more time living their lives.”

(Source: Astria)