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 our Phase 1a clinical trial in healthy subjects support early proof of concept for navenibart’s potential target profile: a long-acting preventative therapy, best-in-class PK profile, and dosing once every 3 and 6 months.
Positive initial proof-of-concept results from the ALPHA-STAR Phase 1b/2 clinical trial evaluating navenibart in HAE patients demonstrate a favorable safety and tolerability profile, mean monthly attack rate reduction of 90-96% for up to 6 months of follow up, and support both three- (Q3M) and six- month (Q6M) dosing regimens. Based on the positive results, we plan to advance navenibart to Phase 3 development with trial initiation expected in Q1 2025 and top-line results expected by year-end 2026.
STAR-0310, a monoclonal antibody OX40 antagonist, is in preclinical development for the potential treatment of atopic dermatitis (AD). STAR-0310 has a potential best-in-class 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 plan to submit an IND for STAR-0310 at the end of 2024 and initiate a Phase 1a trial in the first quarter of 2025, with early proof-of-concept results expected in the third quarter of 2025. Further, we anticipate proof-of-concept results in atopic dermatitis patients in the second quarter of 2026.
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.
