Astria Therapeutics ALPHA-STAR Phase 1b/2 Study Evaluating Navenibart Monoclonal Antibody Inhibitor In Hereditary Angioedema Participants Shows Robust Attack Rate Reduction, Favorable Safety, Tolerability Profile

Author: Benzinga Newsdesk | November 06, 2025 08:14am

Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced positive results from the full enrollment group of 29 patients in the ALPHA-STAR Phase 1b/2 clinical trial evaluating navenibart (STAR-0215), a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema (HAE) 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 (Q3M) and every six-month (Q6M) 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.

ALPHA-STAR is a dose-ranging proof-of-concept trial in adults with HAE Type 1 or 2 designed to assess safety, tolerability, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and quality of life in patients receiving single and multiple doses of navenibart in three cohorts delivered subcutaneously to prevent attacks in HAE. All cohorts began with an eight-week run-in period to measure baseline HAE attacks followed by safety, efficacy, PK, and PD evaluation through 6-months after the last dose received (Day 168, 252, and 196 for Cohorts 1, 2, and 3, respectively). Due to faster-than-expected enrollment and patient interest beyond the original target enrollment of 16, the trial was expanded in Cohorts 2 and 3 and ultimately enrolled a total of 29 patients.

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