FDA fast tracks first-line treatment for hereditary angioedema attacks

The FDA has granted fast-track status to STAR-0215, a potential first-line treatment to prevent attacks of hereditary angioedema, Astria Therapeutics Inc. announced in a company press release.

Results to-date from an ongoing clinical trial have shown that administration every 3 or 6 months of STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein, resulted in “robust suppression” of attacks from the rare genetic disorder, which causes severe, unpredictable swelling throughout the body, according to the press release.

The fast-track designation “underscores the need for HAE therapies that can normalize the lives of people living with HAE,” Jill C. Milne, PhD, Astria CEO, said in the release.

“We look forward to more frequent communication with the FDA as we work to reduce both the disease and treatment burden for the HAE community,” Milne continued.

Initial proof-of-concept results from the phase 1b/2 ALPHA-STAR trial are expected in mid-2024, according to the release.