Astria Therapeutics Gets FDA Nod For Initial-Stage Hereditary Angioedema Study

The U.S. Food and Drug Administration (FDA) announced clearance to Astria Therapeutics’ ATXS Investigational New Drug (IND) application for STAR-0215 in the treatment of Hereditary Angioedema (HAE).

STAR-0215 is designed to provide long-acting, effective attack prevention for HAE with dosing once every 3 months or longer.

The Phase 1a trial evaluating STAR-0215 in healthy volunteers is expected to be initiated in the coming weeks.

Chris Morabito, M.D., Chief Medical Officer, said, ”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. 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.”

The company anticipate Phase 1a preliminary data readout by end of this year.

Price Action : Astria Therapeutics shares are trading around 1.5 percent higher at $3.80 on Thursday at the time of publication.