FDA Grants Fast Track Designation for Astria’s STAR-0215 for the Treatment of Hereditary Angioedema

Rare Daily Staff

The U.S. Food and Drug Administration granted Fast Track designation for Astria Therapeutics’ STAR-0215 for the treatment of hereditary angioedema.

Hereditary angioedema (HAE) is a rare genetic disorder that results in recurring attacks of edema, or swelling, in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The swelling can be debilitating and painful. Attacks that obstruct the airways can cause asphyxiation and are potentially life threatening. HAE attacks may occur very early in childhood. Potentially fatal upper airway angioedema has been reported in patients as young as 3 years old. HAE affects an estimated 1 in 50,000 people worldwide and is often under recognized, under diagnosed, and under treated.

STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE. Astria is developing it to be the first-choice preventative treatment for people with HAE dosed once every three or six months The phase 1b/2 ALPHA-STAR trial evaluating STAR-0215 in HAE patients is ongoing, with proof-of-concept results expected in mid-2024.

“Receiving Fast Track designation for STAR-0215 is an important milestone that underscores the need for HAE therapies that can normalize the lives of people living with HAE with dosing every three or six months,” said Jill Milne, CEO at Astria Therapeutics. “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.”

The FDA Fast Track process is designed to expedite the development and review of therapies to treat serious or life-threatening conditions and that demonstrate the potential to address unmet needs. Companies that receive Fast Track designation for a product candidate are able to submit New Drug Applications for such a candidate on a rolling basis, potentially expediting the FDA review process, and benefit from more frequent communication with the FDA to discuss all aspects of clinical development. In addition, drugs that receive Fast Track designation may be eligible for a priority review if certain criteria are met.

Photo: Jill Milne, CEO at Astria Therapeutics