Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for hereditary angioedema and focused on life-changing therapies for rare and niche allergic and immunological diseases, today announced the U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for STAR-0215, which the company is developing for the treatment of Hereditary Angioedema (HAE). 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.
“The acceptance of our IND by the FDA is an important next step in bringing STAR-0215 to the clinic for our planned first-in-human trial,” said Chris Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “We are optimistic that STAR-0215’s differentiated profile, including dosing once every three months or longer, has the potential to change the way that people with HAE live with their disease.”
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 3 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.