Policy & Regulation
Astria Therapeutics Initiates Phase 1a Trial of STAR-0215, a Monoclonal Antibody Inhibitor of Plasma Kallikrein for Treatment of Hereditary Angioedema
4 August 2022 - - US-based biopharmaceutical company Astria Therapeutics, Inc. (NASDAQ: ATXS) has initiated a Phase 1a clinical trial of STAR-0215 in healthy subjects, the company said.

STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein designed to provide long-acting, effective attack prevention for hereditary angioedema, with dosing once every three months or longer.

Astria anticipates preliminary results from the Phase 1a trial by year-end. The Phase 1a trial is intended to establish clinical proof of concept for the differentiated profile anticipated for STAR-0215.

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 US center.

Approximately 24 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 prolonged half-life and demonstrate inhibition of plasma kallikrein activity, which, if favorable, would provide proof of mechanism for STAR-0215 as a potential best-in-class treatment for HAE.

Preclinically, STAR-0215 has been shown to be a long-acting, potent, and selective inhibitor of plasma kallikrein.

In a study conducted in cynomolgus monkeys, STAR-0215 showed rapid inhibition of plasma kallikrein after subcutaneous administration, and inhibition of high molecular weight kininogen cleavage was rapid and sustained throughout the entire 84-day dose-free period in the extended portion of the study.

These preclinical data support the potential for once every three-month dosing.

Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases.

Its lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema.