STAR-0215

Our lead program candidate, STAR-0215, is a potential best-in-class monoclonal antibody inhibitor of plasma kallikrein that is in clinical development for the treatment of hereditary angioedema. We initiated a Phase 1a clinical trial in 2022, and anticipate preliminary results by year-end.

STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein designed to provide long-acting, effective attack prevention for HAE.

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

CURRENT DEVELOPMENT

  • STAR-0215 is currently in clinical development for the treatment of HAE. We are developing STAR-0215 to be a long-acting monoclonal antibody inhibitor of plasma kallikrein. Targeted plasma kallikrein inhibition can prevent HAE attacks by suppressing the pathway that generates bradykinin and causes excessive swelling.
  • The Food and Drug Administration cleared our Investigational New Drug application for STAR-0215 and we initiated a Phase 1a clinical trial in healthy subject with results anticipated by year-end 2022.
  • The Phase 1a, randomized, double-blind, placebo-controlled, single ascending dose trial is evaluating the safety, pharmacokinetics, and pharmacodynamics of STAR-0215 at a single U.S. center. Approximately 24 healthy subjects will receive a single dose of STAR-0215 or placebo in at least three cohorts of 100mg, 300mg, and 600mg administered subcutaneously.
  • The trial will assess safety and tolerability and aims to establish the prolonged half-life of STAR-0215 and demonstrate inhibition of plasma kallikrein activity, which, if favorable, would provide proof of mechanism.
  • 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 longer.

FUTURE DEVELOPMENT

Pending positive results from the Phase 1a trial, we expect to initiate a multi-center, global Phase 1b/2 trial in people living with HAE in 2023.

REDUCING BURDEN

We are working to reduce the treatment burden for people living with HAE, whose current options for preventative therapies require frequent administration. We believe we can do better with STAR-0215.

Our goal is to provide the most patient-friendly preventative treatment option, with dosing once every 3 months or longer, for people living with HAE.

We are driven to change the way that patients and families live with HAE by allowing them to focus their time and energy on what matters most to them.

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