Astria Therapeutics, Inc. announced the initiation of the ALPHA-STAR Phase 1b/2 clinical trial of STAR-0215 in people living with HAE. Initial proof-of-concept results in HAE patients from single and multiple dose cohorts are expected in mid-2024. The ALPHA-STAR trial is a global open-label Phase 1b/2 proof-of-concept trial enrolling patients with HAE types I and II evaluating safety and tolerability, changes in HAE attack rate, pharmacokinetics, pharmacodynamics, and quality-of-life assessments.

Following an initial run-in period, qualifying participants will be enrolled in either a single or multiple dose cohort. Data from up to 18 participants will evaluate efficacy and safety, and comparisons will be made against data collected during the run-in period. Initial results from the single and multiple-dose cohorts from the ALPHA-STAR trial are expected in mid-2024, and pending positive results, Astria expects to progress directly to a pivotal trial.

STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE. Preliminary results from a Phase 1a trial in healthy subjects supports STAR-0215's target profile: a long-acting preventative therapy, best-in-class PK profile, and dosing once every three months or less frequently. Based on results seen to-date, Astria is planning to evaluate the potential for six-month administration of STAR-0215 in additional cohorts in the Phase 1a trial, with preliminary results expected in the fourth quarter of 2023.