Astria Therapeutics, Inc. announced that preclinical data supporting STAR-0215?s profile as a potential long-acting therapy for hereditary angioedema (HAE) dosed once every three or six months has been published in the Journal of Pharmacology and Experimental Therapeutics. Overview of STAR-0215 Preclinical Results: STAR-0215?s YTE modification in the Fc domain enhances FcRn receptor binding, resulting in a ~3-fold prolonged half-life in cynomolgus monkeys compared to antibodies without this modification; STAR-0215 has a >1000-fold lower affinity for prekallikrein and no measurable inhibitory activity against other serine proteases, demonstrating potent and specific binding for STAR-0215 for human plasma kallikrein; STAR-0215 demonstrated potent in vitro inhibition of plasma kallikrein-mediated bradykinin release from high molecular weight kininogen (HWMK) in a physiologically relevant assay; STAR-0215 achieved inhibition of cleaved HMWK (cHMWK) in cynomolgus monkeys within one day after dosing. This inhibition was sustained throughout the duration of the study, including an 84-day dose-free period, demonstrating both rapid and long-lasting inhibition of plasma kallikrein achievable by subcutaneous administration.

STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE. Initial results from a Phase 1a trial in healthy subjects support STAR-0215?s target profile: a long-acting preventative therapy, best-in-class pharmacokinetic (PK) profile, and dosing once every three or six months. Final results from these three cohorts, as well as initial results from two additional cohorts, are anticipated in the fourth quarter of 2023.

The Phase 1b/2 ALPHA-STAR trial evaluating STAR-0215 in people living with HAE is ongoing, with initial proof-of-concept results from single and multiple dose cohorts expected in mid-2024.