Navenibart (STAR-0215)

Our lead program candidate, navenibart (STAR-0215), is a monoclonal antibody inhibitor of plasma kallikrein designed to provide potential long-acting attack prevention for HAE. The prefix “nav-” represents Astria’s commitment to navigating the development of navenibart with patients as our guiding stars. The infix “-eni-” represents “enzyme inhibitor” and the suffix “-bart” represents “monoclonal antibody.”

Navenibart is in clinical development for the treatment of hereditary angioedema. Based on positive results from the ALPHA-STAR Phase 1b/2 trial in people living with HAE, we are advancing navenibart to Phase 3 development with trial initiation expected in Q1 2025 and top-line results expected in early 2027.

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

CLINICAL DEVELOPMENT

  • Navenibart (STAR-0215) is currently in clinical development for the treatment of HAE.
  • Positive results from the target enrollment group of 16 patients in the Phase 1b/2 ALPHA-STAR trial of navenibart demonstrate a favorable safety and tolerability profile, reduction in the mean monthly attack rate of 90-95% at 6 months, and support both three- (Q3M) and six- month (Q6M) dosing regimens.
  • We are advancing navenibart to Phase 3 development with trial initiation expected in Q1 2025 and top-line results expected in early 2027.

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 navenibart.

Based on the near-term HAE treatment landscape, positive results from target enrollment in the Phase 1b/2 trial support our vision that navenibart can become the market-leading HAE treatment 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.