Astria Therapeutics announces final results from ALPHA-STAR trial

Astria Therapeutics (ATXS) announced results from the full enrollment group of 29 patients in the ALPHA-STAR Phase 1b/2 clinical trial evaluating navenibart, a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema patients. Conducted across 20 sites in six countries, the trial demonstrated robust attack rate reduction, along with a favorable safety and tolerability profile, supporting both every three-month and every six-month dosing regimens. These results reinforce the potential of navenibart’s profile to provide effective, long-acting prevention from HAE attacks and highlight Astria’s strong global clinical execution as the Phase 3 program progresses, with topline results expected in early 2027. Through six months of treatment, expanded Cohorts 2 and 3 had a 62% and 67% attack-free rate, respectively, consistent with previously reported results. Clinically meaningful improvements in patient-reported quality of life were demonstrated at 6 months. Navenibart was generally well-tolerated with no serious treatment-emergent adverse events, no discontinuations, and no injection site reactions of pain. There were four non-severe and quickly resolved treatment-related TEAEs: one case of dizziness, a transient injection site reaction, an injection site erythema, and an injection site pruritus. All 29 patients in the ALPHA-STAR trial elected to enroll in the ALPHA-SOLAR long-term open-label trial and continue receiving navenibart.