Astria Therapeutics, Inc. Announces Positive Initial Results from the Alpha-SOLAR Long-Term Open-Label Trial of Navenibart in Hereditary Angioedema Patients at the European Academy of Allergy and Clinical Immunology Annual Congress

Published: 2025-06-13 07:50:24 ET ATXS

Published on 06/13/2025 at 07:50

Astria Therapeutics, Inc. announced positive initial results from the target enrollment group in the ongoing ALPHA-SOLAR long-term open-label trial evaluating navenibart (STAR-0215), a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema (HAE) patients. These results demonstrated robust overall reduction in the monthly attack rate (92% mean and 97% median). These results further support navenibart?s favorable safety and tolerability profile, and potential every three- (Q3 M) and every six-month (Q6M) dosing regimens.

ALPHA-SOLAR is a long-term open-label trial in adults with HAE Type 1 or 2 designed to assess long-term safety and efficacy of navenibart. All 16 target enrollment participants from the Phase 1b/2 ALPHA-STAR trial elected to enroll in ALPHA-SOLAR. ALPHA-STAR patients from Cohorts 1 and 2 enrolled in Arm A, and ALPHA-STAR patients from Cohort 3 enrolled in Arm B. Navenibart demonstrated overall attack-freedom of 50% over six months, which is the longest period of follow-up for all 16 patients to date.

All patients remain in the ALPHA-SOLAR trial. Navenibart was well-tolerated with no severe or serious treatment-emergent adverse events (TEAEs) and no discontinuations. One participant experienced two treatment-related, mild injection site reactions that resolved without treatment.

There were no injection site reactions of pain. The safety profile of navenibart in patients with HAE was favorable through more than 17 months (median /mean) of cumulative follow-up since the initiation of navenibart in ALPHA-STAR.