The US Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for STAR-0215, an experimental new treatment for hereditary angioedema (HAE).

A phase 1a clinical trial of STAR-0215 in healthy volunteers is expected to begin soon, with preliminary results anticipated before the end of the year, according to a press release from the therapy’s developer, Astria Therapeutics.

“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,” said Chris Morabito, MD, chief medical officer at Astria.


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The clinical trial for STAR-0215 will be a randomized, double-blind, placebo-controlled single ascending trial (NCT05477160). It will assess the safety and tolerability of the therapy as well as its observed half-life in humans. The therapy’s ability to inhibit plasma kallikrein activity will also be tested, and, if successful, would provide evidence of its mechanism of action in patients with HAE.

Read more about experimental therapies for HAE

A total of 24 participants are anticipated to be recruited for the trial from a study site in Wisconsin. Participants will receive a single dose of STAR-0215 or placebo subcutaneously, in at least 3 cohorts of 100 mg, 300 mg, and 600 mg.

STAR-0215 is an investigational monoclonal antibody inhibitor against plasma kallikrein designed to prevent attacks in patients with HAE. Targeting plasma kallikrein is believed to prevent HAE attacks through suppression of the pathway that generates bradykinin and causes excessive swelling. The treatment is also designed to be long-lasting, with dosing required only every 3 months or longer to help maintain protection, based on preclinical testing.

“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,” Dr. Morabito said.

Reference

Astria Therapeutics announces FDA clearance of IND application for STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein for treatment of hereditary angioedema. News release. Astria Therapeutics; July 28, 2022.

STAR-0215. Astriatx.com. Accessed August 4, 2022.

A study of STAR-0215 in healthy adult participants. ClinicalTrials.gov. July 28, 2022. Accessed August 4, 2022.