Astria Therapeutics designs ALPHA-ORBIT Phase 3 trial of navenibart in HAE

Astria Therapeutics (ATXS) announced its planned design of the ALPHA-ORBIT Phase 3 clinical trial of navenibart in people with hereditary angioedema HAE , which will include both every 3- Q3M and every 6-month Q6M treatment arms with the primary analysis at 6 months. Global start-up activities are underway, and ALPHA-ORBIT is expected to initiate in Q1, with top-line results anticipated in early 2027. “We are thrilled to announce our planned Phase 3 design, which reflects feedback from regulators and is intended to support global registration for both Q3M and Q6M administration,” said Jill C. Milne, Ph.D., Chief Executive Officer at Astria. “With navenibart, we are pioneering patient-centric dosing flexibility in HAE with the goal of maximizing attack rate reduction with a compellingly low burden of treatment. Assuming approval, we believe navenibart will become the market-leading, first-choice therapy for HAE.”