Astria Therapeutics Q1 2024 Financial Results and Corporate Update

Astria Therapeutics, Inc., a biopharmaceutical company, recently unveiled its financial results for the first quarter ending March 31, 2024, alongside notable corporate updates. The company is dedicated to developing transformative therapies for allergic and immunological diseases, focusing on two primary programs: STAR-0215 and STAR-0310.

The ALPHA-STAR Phase 1b/2 trial of STAR-0215, aimed at treating hereditary angioedema (HAE), yielded promising initial proof-of-concept results in March 2024. STAR-0215 demonstrated substantial efficacy, reducing monthly attack rates by 90-96% when administered either once or twice over six months. The trial also reported a 92-100% decrease in moderate or severe attacks and a 91-95% reduction in attacks requiring rescue medications. Importantly, STAR-0215 showed favorable safety and tolerability, with no serious adverse events or discontinuations.

Pharmacodynamic data revealed strong, durable inhibition of plasma kallikrein lasting up to six months post-dosing. Additionally, initial pharmacokinetic data aligned with previous Phase 1a modeling. Based on these results, Astria plans to advance STAR-0215 to Phase 3 development. The company aims to start the Phase 3 program with a quarterly (Q3M) dosing regimen by Q1 2025, targeting top-line results by the end of 2026. The Q3M regimen is expected to be life-changing for HAE patients, establishing STAR-0215 as a market leader. Following the Q3M trial, Astria intends to initiate a semi-annual (Q6M) Phase 3 trial to support label expansion and further alleviate the treatment burden for HAE patients.

After completing the ALPHA-STAR trial, patients can continue receiving STAR-0215 in the long-term open-label Phase 2 ALPHA-SOLAR trial, with initial safety and efficacy data expected by mid-2025.

Astria is also developing STAR-0310, a preclinical program targeting atopic dermatitis (AD). This high-affinity monoclonal antibody OX40 antagonist, incorporating YTE technology, has the potential to be best-in-class for AD treatment. Astria plans to submit an Investigational New Drug (IND) application for STAR-0310 by the end of 2024 and commence a Phase 1a clinical trial in healthy subjects in Q1 2025, with initial results anticipated by Q3 2025. The company will present preclinical data on STAR-0310 at the Society for Investigative Dermatology Annual Meeting in May 2024.

In terms of corporate updates, Astria published its first Corporate Social Responsibility (CSR) Report, detailing the company's performance and progress across key Environmental, Social, and Governance (ESG) areas. Additionally, Sunil Agarwal, M.D., joined Astria's Board of Directors, bringing over 20 years of biotechnology research, development, and commercialization experience.

Financial highlights for the first quarter of 2024 include a cash position of $369.9 million, sufficient to fund operations into mid-2027. Research and development expenses rose to $15.7 million, primarily due to the advancement of the STAR-0215 program and associated costs for the STAR-0310 program. General and administrative expenses increased to $8.4 million, reflecting company growth and program support activities. The net loss for the quarter was $19.9 million, with a net loss per share of $0.38.

Astria Therapeutics continues to focus on bringing life-changing therapies to patients with allergic and immunological diseases through its leading programs, STAR-0215 and STAR-0310. With ongoing trials and upcoming milestones, the company aims to advance its mission and establish a strong presence in the biopharmaceutical market.