At the presentation of the company’s financial results for the fourth quarter and full year ended 31 December 2022,  Astria Therapeutics, Inc.‘s CEO Jill C. Milne, Ph.D., says:

“We made excellent progress with our STAR-0215 program in 2022, culminating in the promising initial Phase 1a results. These results support our vision for STAR-0215 to be the first-choice preventative therapy for HAE. The recent initiation of our ALPHA-STAR Phase 1b/2 trial marked an important step towards our goal of reducing the disease and treatment burden as we work to normalize the lives of people with HAE. We look forward to the initial proof-of-concept results from ALPHA-STAR expected in mid-2024.”

STAR-0215 Clinical Development

  • Positive preliminary results from the Phase 1a clinical trial of STAR-0215 in healthy subjects were announced in December 2022 and initial unblinded results from the first three cohorts were presented at the American Academy of Allergy Asthma, and Immunology Annual Meeting (AAAAI) in February 2023. STAR-0215 was well-tolerated at all doses studied. The results showed rapid and sustained drug levels, with an estimated half-life of up to 117 days and sustained target engagement with plasma kallikrein inhibition for at least three months. These results establish early proof of concept for STAR-0215 as a long-acting preventative therapy for HAE.
  • The Company initiated the ALPHA-STAR Phase 1b/2 trial of STAR-0215 in people with HAE in February 2023. Initial proof-of-concept results are expected in mid-2024. The ALPHA-STAR trial is a global, open-label, proof-of-concept trial enrolling patients with HAE types I and II that is 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 single or multiple dose cohorts. Data from up to 18 participants will evaluate efficacy and safety, and comparisons will be made against data collected in the run-in period. Pending proof-of-concept results from the ALPHA-STAR trial, Astria expects to progress directly to a pivotal trial.
  • Astria is also evaluating the potential for administration of STAR-0215 every six months in additional cohorts in the Phase 1a trial, with preliminary results expected in the fourth quarter of 2023. These data, in conjunction with the ALPHA-STAR results, are expected to inform plans for the pivotal trial.

(Source: Astria)