Astria reports Q4 and full year 2023 financial results and provides a corporate update

Astria Therapeutics reports fourth quarter and full year 2023 financial results and provides a corporate update

Astra Therapeutics today announced today reported financial results for the fourth quarter and full year ended 31 December 2023, and provided a corporate update.

Jill C Milne, Chief Executive Officer at Astria Therapeutics, said: “We have strong conviction in the potential for STAR-0215 to be the first-choice preventative therapy for HAE. Our final data from the Phase 1a trial demonstrate that STAR-0215, in addition to having a trusted modality and proven mechanism, has a favorable safety profile with low risk of injection site pain and has the potential to achieve rapid and durable protection against HAE attacks. We are looking forward to sharing initial proof-of-concept data in HAE patients this quarter and believe they could support dosing as infrequently as every six months.”

STAR-0215

• The ALPHA-STAR Phase 1b/2 trial of STAR-0215 in people with hereditary angioedema (HAE) is on track. Initial proof-of-concept results are expected in the first quarter of 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 (PK), pharmacodynamics (PD), and quality-of-life assessments. The initial proof-of-concept results are expected to inform on three and six month dosing and include efficacy results in the form of attack rate reduction, safety and tolerability, PK, and PD. Additionally, the company expects to have data from single and multiple doses in patients.
• Pending proof-of-concept results from the ALPHA-STAR trial, Astria expects to progress directly to a pivotal Phase 3 program which is anticipated to initiate in the first quarter of 2025.
• A Long-Term Open-Label Trial, ALPHA-SOLAR, has been initiated and is enrolling participants from ALPHA-STAR, with data from participants who have received multiple doses of STAR-0215 now accruing. The trial is assessing the long-term safety, tolerability, and efficacy of STAR-0215. Participants are receiving STAR-0215 every three or six months.
• Final results from the Phase 1a trial were shared at the AAAAI Annual Meeting in Washington DC. These results confirm early proof of concept in healthy subjects for STAR-0215 as a potential preventative HAE therapy with a favorable safety profile, long half-life, and durable PD.

(Source: Astria)