Our lead program, STAR-0215, is in preclinical development to treat hereditary angioedema (HAE), a rare genetic disorder characterized by severe, recurrent, unpredictable, painful, and sometimes life-threatening swelling in the face, limbs, abdomen, and airway.
Learn how STAR-0215 aims to prevent attacks in HAE by exploring the mechanism of action here:
STAR-0215 is currently in preclinical 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.
Preclinical results 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.
We expect to file an Investigational New Drug application for STAR-0125 in mid-2022, and plan to initiate a Phase 1a clinical trial shortly thereafter with initial results anticipated by year-end. We plan to conduct the Phase 1a trial in healthy volunteers with subcutaneous administration.
The goals of this initial proof of concept trial are to demonstrate safety and tolerability, establish the prolonged half-life of STAR-0215, and to demonstrate inhibition of plasma kallikrein activity. We plan to initiate a Phase 1b/2 trial in HAE patients in 2023.
We are working to 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.