Astria Therapeutics reports third quarter financial results and provides a corporate update

Astra Therapeutics reported financial results for the third quarter ended 30 September 2023 and provided a corporate update.

Jill C. Milne, PhD, Chief Executive Officer at Astria Therapeutics, said: “We are realizing our vision of growing an allergy and immunology company with a pipeline of potential best-in-class therapies. The STAR-0215 program is in a strong position, and data from the Phase 1a healthy subject trial recently shared at ACAAI support the potential to provide patients with dosing options two or four times per year, without compromising on safety or efficacy. We now expect to deliver initial proof-of-concept results in Q1 2024 from the Phase 1b/2 ALPHA-STAR trial in HAE patients. We are excited about the future for Astria as we work towards important milestones for STAR-0215 and STAR-0310 next year.”

STAR-0215

  • Additional results from the Phase 1a trial were shared at the ACAAI Annual Meeting in Anaheim, CA. STAR-0215 was well-tolerated with no serious adverse events or discontinuations due to an adverse event, and low risk of injection pain. STAR-0215 achieved potentially therapeutic levels in less than one day and showed an estimated half-life of up to 127 days. Pharmacokinetic (PK) modeling of every 3 month and every 6 month clinical dose regimens predict concentrations that will continuously maintain drug levels believed to be sufficient for HAE attack prevention. Pharmacodynamic (PD) data showed statistically significant inhibition of plasma kallikrein for 140 to 224 days after single doses greater than 100 mg. These results demonstrate 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.
  • The ALPHA-STAR Phase 1b/2 trial of STAR-0215 in people with hereditary angioedema (HAE) is on track and enrolling the third and final cohort. Initial proof-of-concept results are now 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, PK, PD, 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.
  • A Long-Term Open-Label Trial named ALPHA-SOLAR has been initiated and is enrolling participants from ALPHA-STAR, with data now accruing in participants who have received multiple doses of STAR-0215. The trial is assessing the long-term safety, tolerability, and efficacy of STAR-0215. Participants are receiving 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 Phase 3 trial which is anticipated to initiate in the first quarter of 2025.
  • Additional preclinical results were shared in the Journal of Pharmacology and Experimental Therapeutics that support STAR-0215’s potential as a best-in-class plasma kallikrein inhibitor.
  • Astria presented at the Hereditary Angioedema Association (HAEA) National Summit in July, and the Hereditary Angioedema International EMEA meeting in September, sharing results from a research survey where patients prioritized attack-free status as their most important target for therapeutic efficacy in HAE clinical trials.

(Source: Astria)