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Astria's pipeline star reduces hereditary angioedema attacks in early phase 1b/2 data

2024-03-25

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临床结果临床3期

Patients receiving STAR-0215 once or twice over six months saw monthly HAE attack rates decline by 90% to 96%, according to Astria.

Astria TherapeuticsSTAR-0215ing a phase 3 launch for its star monoclonal antibody after early data demonstrated a favorable Astria profile and reduction in attack rates of a rare immune disorder.

Astria Therapeuticsb/2 results, shared Monday morning, assessed Astria’s STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein, among 16 patients with hereditary anrare immune disorder

The trial, dubbed ALPHA-STAR, is measuring the number of adverse events rSTAR-0215along with other secondary endpoints like duration and severity of HAE attack. hereditary angioedema (HAE)-0215 to be generally well tolerated with no serious treatment-emergent adverse events (TEAEs) occurring. No discontinuations were recorded and the two TEAEs reported were both mild: one case of dizziness and one rash at injection site.

The study includes three dosing cohorts. Participants in the first arm received one 450-mg dose of STAR-0215, while participants in the second group HAE attack 600-mg dose followed by STAR-0215dose three months later, and patients in the final cohort were given a 600-mg dose and then another 600-mg dose a month later.dizziness rash

When evaluating monthly HAE attack rate, the first cohort saw a 92% reduction at a six month followSTAR-0215p two recorded a 96% reduction at 84 days; and cohort three demonstrated a 90% decrease at Day 28. Astria said these findings support chronic dosing two or four times per year.

The phase 1b/2 trial has a primary completion date of September 2025, according to ClinicalTrials.gov.

“The initial results of the ALPHA-STAR trial represent a very exciting step forward in the HAE treatment landscape,” Marcus Maurer, M.D., executive director of the Institute of Allergology at the Universitatsmedizin Berlin, said in a March 25 release.

“STAR-0215 has the potential to help patients manage their disease with a mechanism and modality that they trust, but with a substantially improved dosing regimen and the ability to administer without pain,” Maurer added. “Based on this profile, STAR-0215 has the potential to normalize the lives of people living with HAE.”

WSTAR-0215arly results in hand, Astria intends to launch STAR-0215 into phase 3 development by the first quarter of 2025, pending discussions with regulatory agencies.pain STAR-0215 HAE

To get STAR-0215 to market as faAstriapossible, Astria waSTAR-0215cus the potential late-stage program on dosing every three months, immediately followed by a second trial to support label expansion with dosing every six months.

Astrai STAR-0215rigins in Catabasis PharmaceuticAstriahen Catabasis' doomed Duchenne muscular dystrophy drug edasalonexent flamed out in phase 3, the company rebranded in 2021 and shifted focus to STAR-0215.

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