Astria Therapeutics, Inc. initiates 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.
“Our vision for STAR-0215 is to develop a long-acting, safe, and effective preventative therapy that normalizes the lives of people living with HAE,” says Chris Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “After seeing promising Phase 1a clinical results at the end of last year, we are proud to be taking the next step forward by evaluating STAR-0215 in HAE patients in our proof-of-concept clinical trial. We believe that STAR-0215 has the potential to change the way that people live with their HAE.”
“We are thrilled that STAR-0215 is moving forward in development with a thoughtfully planned clinical trial that takes our patient community into consideration by allowing all qualifying participants to receive STAR-0215,” says Dr. Marcus Maurer, M.D., Professor of Dermatology and Allergy at Charité Universitätsmedizin in Berlin, Germany. “The HAE community is looking for treatments that have the potential to be less burdensome on their lives. ALPHA-STAR is designed to efficiently assess the potential of STAR-0215, and I am looking forward to the expected proof-of-concept results mid-next year.”
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 support 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.