Astria Therapeutics recently announced the initiation of the ALPHA-STAR phase 1b/2 clinical trial of STAR-0215 in patients with hereditary angioedema (HAE).

Initial proof-of-concept results from single and multiple dose cohorts are anticipated by mid-2024, and, pending positive results, Astria expects to progress to a pivotal trial.

“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,” Chris Morabito, MD, chief medical officer at Astria Therapeutics, said. “We believe that STAR-0215 has the potential to change the way that people live with their HAE.”

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The global, open-label, phase 1b/2 proof-of-concept trial is set to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of STAR-0215 as well as changes in HAE attack rate and quality of life in patients with HAE types 1 and 2. Data obtained from up to 18 eligible participants, belonging to either a single- or multiple-dose cohort, will be compared with data collected during the run-in period.

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According to preliminary results from a phase 1a trial in healthy subjects, the drug may have a best-in-class pharmacokinetic profile and perform as long-acting preventive therapy with dosing once every 3 months.

Next, the pharmaceutical company will evaluate the potential for 6-month administration in additional cohorts and release preliminary results in the last quarter of 2023.

“The HAE community is looking for treatments that have the potential to be less burdensome on their lives,” Marcus Maurer, MD, professor of dermatology and allergy at Charité Universitätsmedizin in Berlin, Germany, stated in a press release.


Astria Therapeutics initiates ALPHA-STAR phase 1b/2 clinical trial of STAR-0215 in people with HAE. News release. Astria Therapeutics, Inc; February 8, 2023.