HAE therapy STAR-0215 wins FDA’s fast track designation

Astria Therapeutics is testing treatment's safety, tolerability in Phase 1b/2 study

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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The U.S. Food and Drug Administration (FDA) has given STAR-0215 fast track status to help speed up its development and make it available to patients sooner.

An experimental medication to prevent swelling attacks in hereditary angioedema (HAE), with dosing once every three or six months, STAR-0215 is in the pipeline of Astria Therapeutics.

“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,” Jill C. Milne, PhD, Astria’s CEO, said in a company press release.

The company is conducting ALPHA-STAR (NCT05695248), a Phase 1b/2 trial that’s testing how safe and well tolerated STAR-0215 is either as a single injection under the skin or as two injections one or three months apart. It’s also looking at how well it works to prevent or shorten swelling attacks, its pharmacokinetics (how it moves through the body), and its immunogenicity, that is, whether it triggers an immune response.

With eight active sites in the U.S. and one in Canada, the trial is recruiting adults with HAE types 1 or 2 who’ve had at least two swelling attacks in a run-in period preceding dosing and aren’t on preventive treatment.

Initial proof-of-concept results are expected by mid-2024. If positive, the company intends to move directly into a pivotal trial to support a new drug application (NDA) STAR-0215’s approval.

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Kallikrein Inhibitor STAR-0215 Has Long-lasting Effect in Monkeys

What is STAR-0215 and how does it work?

In HAE, the enzyme kallikrein becomes too active and causes a signaling molecule called bradykinin to build up. Bradykinin makes blood vessels dilate and causes fluid to leak into nearby tissues, resulting in swelling.

STAR-0215 is an antibody designed to block kallikrein’s activity. This is expected to lower bradykinin levels, which should help prevent swelling attacks.

In a Phase 1a trial (NCT05477160), a single dose led to the rapid and sustained inhibition of kallikrein in healthy adults, an effect that supports dosing every three months or longer.

The company is also testing dosing every six months in an additional group of healthy adults as part of the Phase 1a trial. The results are expected by year’s end.

Getting fast track designation for an experimental medication means the FDA recognizes its potential to help people with urgent medical needs, like those with diseases for which there aren’t many effective treatments available.

With the designation, the company can submit paperwork for an NDA on a rolling basis more flexibly and in stages instead of having to wait until they have all the necessary information at once. It may also benefit from having more frequent communication with the FDA and eligibility to priority review.

“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 said.