Astria Therapeutics provided an update on development of STAR-0215 for HAE as part of reporting on financial results for the second quarter of 2023

Astria Therapeutics, a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema (HAE) and focused on life-changing therapies for rare and niche allergic and immunological diseases, today reported financial results for the second quarter that ended June 30, 2023, and provided a corporate update.

Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics, said: “We are making excellent progress with our STAR-0215 program and are proud to have received Fast Track Designation for the treatment of HAE.

“We believe that STAR-0215 has the profile of a potential first-choice preventative therapy for HAE based on its well-established mechanism, trusted modality, long half-life, and potential for infrequent dosing. We are looking forward to sharing additional data from our Phase 1a trial in Q4. We expect these results will provide additional information on dose selection for three and six-month administration, with data on safety, tolerability, pharmacokinetics, and pharmacodynamics from a wide range of single dose levels.”

The company highlighted the following developments:

  • STAR-0215 was granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of HAE.
  • The ALPHA-STAR Phase 1b/2 trial of STAR-0215 in people with HAE is progressing well. Initial proof-of-concept results are expected in mid-2024. ALPHA-STAR is a global, open-label, proof-of-concept trial assessing single and multiple doses of STAR-0215 in patients with HAE types I and II. The trial is evaluating safety and tolerability, changes in HAE attack rate, pharmacokinetics, pharmacodynamics, and quality-of-life assessments. For each dose cohort, efficacy will be assessed at 3 months and 6 months after the last STAR-0215 dose administered.
  • In the fourth quarter of 2023, the company expects to announce final results from three single dose cohorts in healthy subjects. Initial results from the two additional dose-ranging cohorts in healthy subjects are also expected to be shared in Q4. Overall, the data are expected to provide more information around plans for future trials, dose selection for potential three and six-month administration, safety and tolerability, and PK and PD from a wide range of single dose levels.
  • A Long-Term Open-Label Trial named ALPHA-SOLAR will be open to participants from ALPHA-STAR and is expected to initiate in the fourth quarter of 2023. It will assess the long-term safety, tolerability, and efficacy of STAR-0215. Participants will be assigned to a dosing regimen based on their cohort assignment in the ALPHA-STAR trial, and all are expected to receive STAR-0215 every three or six months.
  • Pending proof-of-concept results from the ALPHA-STAR trial, Astria expects to progress directly to a pivotal trial.
  • In June 2023, Astria presented at the European Academy of Allergy and Clinical Immunology Annual Meeting in Hamburg, Germany. Results included an overview of the design of the ALPHA-STAR clinical trial, a summary of the positive initial Phase 1a results of STAR-0215 in healthy subjects, and details about STAR-0215’s differentiated mode of plasma kallikrein binding.
  • Human mechanistic modeling data were presented at the C1-Inhibitor Deficiency and Angioedema Workshop in May 2023. These data support the potential for STAR-0215 to be administered once every three or six months for robust suppression of HAE attacks. Additionally, Principal Investigator Dr. Marcus Maurer presented the ALPHA-STAR trial, including design, dose selection rationale, and partnerships with the HAE community.

STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE, with dosing every three or six months. The Phase 1b/2 ALPHA-STAR trial evaluating STAR-0215 in HAE patients is ongoing, with proof-of-concept results expected in mid-2024.

(Source: Astria Therapeutics Inc)