Positive Early Results for STAR-0215 in HAE Trial

Astria Therapeutics, a biopharmaceutical enterprise, has reported promising early outcomes from their Phase 1b/2 clinical trial of STAR-0215, a monoclonal antibody designed to inhibit plasma kallikrein for hereditary angioedema (HAE) treatment. The drug showed a significant reduction in attack rates, with a 90-96% decrease observed over a six-month period. This supports the potential for chronic dosing twice or four times a year.

The drug was found to be very well-tolerated, with no serious adverse events reported and no patients discontinuing treatment. It also demonstrated a 92-100% decrease in moderate or severe attacks and a 91-95% reduction in the need for rescue medications. The positive results have encouraged Astria to plan for Phase 3 trials, which are expected to begin in the first quarter of 2025, with top-line results anticipated by the end of 2026.

The company's current financial resources are projected to sustain operations until mid-2027, covering the development of STAR-0215 through the planned Phase 3 trial and the advancement of their STAR-0310 OX40 program. The ALPHA-STAR trial, which has already met its target enrollment, is assessing the safety, efficacy, and impact on quality of life of STAR-0215 in HAE patients. The trial involves various dosing regimens, with preliminary data indicating substantial efficacy and a favorable pharmacokinetic and pharmacodynamic profile.

Astria Therapeutics aims to provide a transformative therapy for HAE patients, reducing the burden of disease and treatment. The company is optimistic about the potential of STAR-0215 to become a first-choice treatment for HAE, thanks to its rapid onset of action and pain-free administration. The enthusiasm for the drug led to the trial enrolling ahead of schedule, allowing for earlier data reporting.

The company will host a webcast to discuss the results and future plans for the development of STAR-0215. Astria Therapeutics is committed to delivering life-changing therapies for patients affected by allergic and immunological diseases, with STAR-0215 and STAR-0310 being key programs in their pipeline.