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Astria Therapeutics Initiates ALPHA-STAR Phase 1b/2 Clinical Trial of STAR-0215 in People with HAE
The ALPHA-STAR Phase 1b/2 clinical trial of STAR-0215 in patients with HAE will begin, according to a February 8 announcement from Astria Therapeutics. Mid-2024 is the anticipated time for the first proof-of-concept findings in HAE patients from single- and multiple-dose cohorts.
“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,” said 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,” said Dr. Marcus Maurer, M.D., Professor of Dermatology and Allergy at Charité Universitätsmedizin in Berlin. “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.”
Patients with HAE types I and II are enrolled in the ALPHA-STAR trial, a global open-label Phase 1b/2 proof-of-concept study that assesses quality of life, safety, and tolerability as well as changes in the attack rate of HAE. Qualifying participants will be enrolled in either a single or multiple dose cohort after an initial run-in period. Effectiveness and safety will be assessed using information from up to 18 participants, and it will be compared to information gathered during the run-in period. Early findings from the single- and multiple-dose cohorts of the ALPHA-STAR trial are anticipated in mid-2024, and if promising, Astria anticipates moving right into a pivotal trial.
For the treatment of HAE, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein, is being developed. Initial findings from a Phase 1a trial in healthy volunteers support STAR-0215’s target profile, which includes a long-acting preventative therapy, a best-in-class PK profile, and dosing once every three months or less frequently. Astria intends to assess the feasibility of STAR-0215 administration for six months in additional cohorts in the Phase 1a trial based on the results so far, with preliminary findings anticipated in the fourth quarter of 2023.
