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. After receiving positive preliminary results from our Phase 1a trial in healthy subjects, we plan to initiate our ALPHA-STAR Phase 1b/2 trial in people living with HAE in early 2023.

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.
  • We announced positive preliminary results from our Phase 1a clinical trial of STAR-0215 in healthy subjects in 2022. Based on these preliminary results, we are also planning to evaluate the potential for 6-month dosing with additional cohorts in the Phase 1a trial starting in Q1 2023 with results expected in Q4 2023.
  • We are progressing STAR-0215 to patients. We plan to initiate the ALPHA-STAR Phase 1b/2 trial in HAE patients in Q1 2023. We expect initial results from single and multiple dose cohorts in mid-2024.

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 months or less frequently.

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 support our vision that STAR-0215 can become the new standard of care for HAE attack prevention.

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.

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