1 August 2022 - - The US Food and Drug Administration has cleared US-based biopharmaceutical company Astria Therapeutics, Inc's (NASDAQ: ATXS) Investigational New Drug application for STAR-0215, which the company is developing for the treatment of Hereditary Angioedema, the company said.

A Phase 1a trial of STAR-0215 in healthy volunteers is expected to initiate in the coming weeks, with preliminary results anticipated by year-end.

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

The company's goal is to provide the most patient-friendly preventative treatment option for people living with HAE.

The Phase 1a trial is planned to be a randomized, double-blind, placebo-controlled trial evaluating STAR-0215 in healthy volunteers.

The goals for the trial include assessing safety and tolerability, establishing the prolonged half-life of STAR-0215, and inhibition of plasma kallikrein activity, which, if favorable, would provide proof of mechanism in HAE.

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 preclinical development for the treatment of hereditary angioedema.