Hereditary angioedema is characterised by regular, unpredictable attacks that lead to tissue swelling. The face is commonly affected. Image credit: Shutterstock/Velimir Zeland.

The US Food and Drug Administration (FDA) has granted fast track designation to Astria Therapeutics for its hereditary angioedema candidate STAR-0215.

STAR-0215 is currently being investigated in a Phase Ib/II trial (NCT05695248) in patients, in what is the first time the drug has been given to participants with hereditary angioedema.

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Hereditary angioedema is an inherited disorder that is characterised by unpredictable attacks that result in rapid swelling of tissues. The face, limbs, intestinal tract, and airway are commonly affected areas. 

The primary endpoint of the trial is the number of participants experience treatment-emergent adverse effects. Secondary endpoints include changes in the number of attack events from baseline and attack duration. Proof-of-concept results are expected halfway through 2024.

Human C1 esterase inhibitor (marketed as Cinryze), berotralstat (marketed as Orladeyo), lanadelumab (marketed as Takhzyro), tranexamic acid, and danazol are all current treatments to help prevent attacks, but require regular doses.

Based in Boston, US, Astria Therapeutics says it hopes STAR-0215, via doses once every three or six months, will become the first-choice preventative treatment for people with the disorder.

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The company’s candidate is a subcutaneously administered monoclonal antibody inhibitor of plasma kallikrein. During an attack, plasma kallikrein levels are elevated. Via its cleaving action of kininogen and subsequent bradykinin production, plasma kallikrein leads to tissue swelling.

The company announced positive preliminary Phase Ia results of the candidate in December 2022. 

Astria Therapeutics’ CEO Jill C Milne said: “Receiving fast track designation for STAR-0215 is an important milestone that underscores the need for HAE therapies that can normalise the lives of people living with HAE with dosing every three or six months. 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.”

Reacting to the preliminary results announcement in December 2022, Dr William Lumry, founder and medical director of the AARA Research Center said: “Patients want treatment options that can normalise their lives. I am pleased to see STAR-0215 moving forward in clinical development for patients. We understand the need from the hereditary angioedema community for effective treatment with less burdensome dosing administration and are excited to see that potential in STAR-0215.”