Astria Therapeutics Announces FDA Clearance of IND Application for STAR-0215, a Monoclonal Antibody Inhibitor of Plasma Kallikrein for Treatment of Hereditary Angioedema

BOSTON, MA, USA I July 28, 2022 I 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.

About Astria Therapeutics:
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. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in preclinical development for the treatment of hereditary angioedema. Learn more about our company on our website, www.astriatx.com, or follow us on Twitter and Instagram @AstriaTx and on Facebook and LinkedIn.

SOURCE: Astria Therapeutics

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