09:01 AM EDT, 09/30/2024 (MT Newswires) -- Astria Therapeutics ( ATXS ) said Monday that the US Food and Drug Administration has granted Orphan Drug Designation to navenibart for the treatment of hereditary angioedema.

Orphan status is given medicines intended to prevent, diagnose and treat rare diseases or disorders that affect less than 200,000 people in the US, Astria said.

The company said that based on initial data from a phase 1b/2 clinical trial, navenibart had a "favorable" safety and tolerability profile and cut monthly attack rates by 90% to 96% when dosed once or twice over six months.

Astria expects to release more results from the trial in Q4 and to progress navenibart into a phase 3 trial initiating in Q1 of 2025, said Chief Executive Jill Milne.