STAR-0215

Our lead program candidate, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein designed to provide potential long-acting attack prevention for HAE.

STAR-0215 is in clinical development for the treatment of hereditary angioedema. Based on positive initial results from the ALPHA-STAR Phase 1b/2 trial in people living with HAE, we plan to advance STAR-0215 to Phase 3 development with trial initiation expected in Q1 2025 and top-line results expected by year-end 2026.

Learn how STAR-0215 aims to prevent attacks in HAE by exploring the mechanism of action here:

CLINICAL DEVELOPMENT

  • STAR-0215 is currently in clinical development for the treatment of HAE.
  • Positive initial proof-of-concept results from the Phase 1b/2 ALPHA-STAR trial of STAR-0215 in people living with HAE 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 every three- and six- month dosing regimens.
  • Based on these positive results, we plan to advance to Phase 3 development with trial initiation expected in Q1 2025 and top-line results expected by year-end 2026.

PRECLINICAL DEVELOPMENT

Preclinical results to date show STAR-0215’s differentiated profile, with high potency and a long plasma half-life, predicting that STAR-0215 could be an effective preventative therapy with the potential for dosing once every 3 and 6 months.

REDUCING BURDEN

We’ve heard from the HAE community the desire to normalize their lives, living without limitations from their symptoms and treatments. Our goal is to reduce the disease and treatment burden for people living with HAE, whose current options for preventative therapies require frequent administration (daily or up to every 4 weeks). We believe we can do better with STAR-0215.

Based on the near-term HAE treatment landscape, our Phase 1a data and Phase 1b/2 initial proof-of-concept results support our vision that STAR-0215 can become the new standard of care for HAE attack prevention with dosing every 3 and 6 months.

We are driven to help patients and families normalize their lives by developing a treatment that allows them to focus their time and energy on what matters most to them.