Our lead program candidate, navenibart (STAR-0215), is a potential best-in-class monoclonal antibody inhibitor of plasma kallikrein designed to provide long-acting, safe, and effective attack prevention for HAE, with potential for dosing once every 3 and 6 months.
Positive results from target enrollment in the ALPHA-STAR trial of navenibart support both every three- (Q3M) and six- month (Q6M) dosing regimens and demonstrate a favorable safety and tolerability profile, as well as reduction in the mean monthly attack rate of 90-95% at 6 months. We are advancing navenibart to Phase 3 development, with trial initiation expected in Q1 2025 and top-line results expected in early 2027.
STAR-0310, a monoclonal antibody OX40 antagonist, is in clinical development for the potential treatment of atopic dermatitis (AD). STAR-0310 has a potential best-in-class OX40 inhibitor profile: high affinity for competitive efficacy, potential for best-in-class safety and tolerability with low T cell depletion from ADCC or possible on-target cellular toxicity, and less frequent dosing.
We initiated a Phase 1a trial of STAR-0310 in healthy subjects in January of 2025, which is intended to assess the safety, tolerability, pharmacokinetics, and immunogenicity of STAR-0310 in healthy adult participants. We expect early proof-of-concept results from the Phase 1a trial in the third quarter of 2025.
At Astria, we are focused on developing differentiated therapeutics for allergic and immunologic diseases. Our pipeline represents our vision to improve patients’ quality of life by creating first-choice treatments based on established mechanisms designed to reduce disease and treatment burden.
Safety and efficacy for our product candidates have not been established. There is no guarantee that the outcome of these studies will be positive or result in the approval by a Health Authority.
