Phase 1b/2 trial of STAR-0215 is now enrolling HAE patients

STAR-0215 is made to be more long-lasting than other kallikrein inhibitors

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Astria Therapeutics has initiated a Phase 1b/2 trial called ALPHA-STAR to test STAR-0215, the company’s investigational therapy to prevent swelling attacks in people with hereditary angioedema (HAE).

ALPHA-STAR (NCT05695248) intends to enroll 18 adults with HAE types 1 or 2 who have had at least four swelling attacks in the past year and are not on preventive therapy. Enrollment is currently ongoing at a site in California and additional information is available at the study’s website.

“We are thrilled that STAR-0215 is moving forward in development with a thoughtfully planned clinical trial that takes our patient community into consideration by allowing all qualifying participants to receive STAR-0215,” said Marcus Maurer, MD, a professor at Charité Universitätsmedizin, Berlin, in a press release.

After a run-in period, participants will receive either a single subcutaneous (under-the-skin) injection or two injections three months apart.

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The study’s main goal is to assess treatment safety. Measures of effectiveness, such as the rate and severity of swelling attacks, also will be assessed. The trial is expected to provide proof-of-concept data to back up the efficacy of STAR-0215 in HAE. Results are expected in mid-2024.

The therapy is made to block the activity of kallikrein, a protein that helps produce the signaling molecule bradykinin. In HAE, swelling attacks are triggered by abnormally high bradykinin levels. STAR-0215 should be more long-lasting than other therapies that target kallikrein, allowing for less frequent dosing.

“The HAE community is looking for treatments that have the potential to be less burdensome on their lives. ALPHA-STAR is designed to efficiently assess the potential of STAR-0215, and I am looking forward to the expected proof-of-concept results mid-next year,” Maurer said.

Astria’s announcement came less than two months after the company released positive preliminary data from a Phase 1a trial (NCT05477160) that tested STAR-0215 in healthy volunteers. Results showed a single dose led to rapid and sustained inhibition of kallikrein, with an effect that appeared consistent with dosing every three months.

“We were encouraged by our Phase 1a results at the end of last year and are optimistic that STAR-0215 can be a safe, effective, long-acting preventative treatment for people living with HAE. The initiation of the ALPHA-STAR trial marks the next important step in delivering on our commitment to helping HAE community,” Jill Milne, Astria’s CEO, told Angioedema News in an email.

Astria also plans to test a prolonged dosing regimen, wherein STAR-0215 would be administered every six months, in additional healthy volunteers in the Phase 1a trial. Preliminary data from these dosing groups is expected later this year, according to Astria.