Astria Reports Favorable STAR-0215 Phase 1b/2 HAE Trial Outcomes

Astria Therapeutics, a biopharmaceutical firm, has reported promising preliminary results from the ALPHA-STAR Phase 1b/2 clinical trial of STAR-0215, a monoclonal antibody designed to inhibit plasma kallikrein in patients with hereditary angioedema (HAE). The drug demonstrated a significant reduction in monthly attack rates, with a 90-96% decrease observed in patients treated with either a single or double dose over six months. This supports the feasibility of a chronic dosing schedule of two or four times per year. The medication also led to a 92-100% decrease in moderate or severe attacks and a 91-95% reduction in the need for rescue medications. Importantly, STAR-0215 was found to be well-tolerated, with no serious adverse events reported and no treatment discontinuations.
The company is on track to initiate Phase 3 trials in Q1 2025, with preliminary data expected by the end of 2026. Astria's current financial resources are anticipated to sustain the company's operations until mid-2027. A conference call discussing the results was held on the same day as the announcement.
In the ALPHA-STAR trial, three different dosing cohorts were evaluated. The first cohort, receiving a 450 mg dose, showed a 92% reduction in monthly attack rates, a 96% reduction in moderate to severe attacks, and a 91% reduction in the use of acute rescue medication. The second and third cohorts, receiving 600 mg doses with varying intervals, also showed significant reductions in attack rates and medication use, with a rapid onset of action observed in the first month post-dosing.
The positive preliminary pharmacokinetic and pharmacodynamic data, along with the safety profile, support the progression of STAR-0215 into Phase 3 development. Astria plans to initially focus on a quarterly dosing regimen for the Phase 3 program, with a subsequent trial to support a six-monthly dosing option. The company's current cash reserves, supplemented by recent financing, are projected to cover all activities related to the STAR-0215 program through the completion of the planned Phase 3 trial, as well as the advancement of the STAR-0310 OX40 program.
Astria Therapeutics is dedicated to developing transformative therapies for allergic and immunological diseases, with STAR-0215 as their lead program for HAE treatment and STAR-0310 in preclinical development for atopic dermatitis. The company aims to provide patients with HAE a life-improving treatment option that reduces the burden of their disease and treatment, with the potential to become the preferred choice for HAE management.

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