Astria Therapeutics recently announced that the development program for its drug candidate, STAR-0215, has been granted Fast Track Designation by the US Food and Drug Administration (FDA) for the treatment of hereditary angioedema (HAE).

“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 C Milne, PhD, chief executive officer 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.”

Currently, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein designed for the treatment of HAE, is undergoing evaluation in the phase 1b/2 ALPHA-STAR clinical trial in people with HAE. The trial aims to assess the efficacy and safety of STAR-0215, and initial proof-of-concept results are anticipated to be available in mid-2024.

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As clinical development progresses, Astria Therapeutics remains committed to advancing their vision of making STAR-0215 the preferred preventative treatment option for individuals with HAE, dosed once every 3 or 6 months, with the ultimate goal of achieving substantial progress toward normalizing the lives of patients.

Read more about experimental therapies for patients with HAE

The Fast Track Designation highlights the potential significance of STAR-0215 in addressing the urgent medical needs of patients with HAE. Upon receiving this designation for a drug candidate, companies gain the advantage of submitting New Drug Applications for that candidate on a rolling basis, which can potentially expedite the FDA review process.

In addition, they benefit from increased communication opportunities with the FDA, facilitating discussions on all aspects of clinical development. Moreover, drugs that secure Fast Track Designation may also be eligible for a priority review, provided they meet specific criteria.


Astria Therapeutics receives fast track designation for STAR-0215 for the treatment of hereditary angioedema. News release. Astria Therapeutics, Inc.; July 20, 2023.