STAR-0215

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.