Patients receiving STAR-0215 once or twice over six months saw monthly HAE attack rates decline by 90% to 96%, according to Astria. Astria Therapeutics is planning a phase 3 launch for its star monoclonal antibody after early data demonstrated a favorable safety profile and reduction in attack rates of a rare immune disorder. The initial phase 1b/2 results, shared Monday morning, assessed Astria’s STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein, among 16 patients with hereditary angioedema (HAE). The trial, dubbed ALPHA-STAR, is measuring the number of adverse events reported, along with other secondary endpoints like duration and severity of HAE attack. The initial data found STAR-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 received a 600-mg dose followed by a 300-mg dose three months later, and patients in the final cohort were given a 600-mg dose and then another 600-mg dose a month later. When evaluating monthly HAE attack rate, the first cohort saw a 92% reduction at a six month follow-up; group 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.” With the early results in hand, Astria intends to launch STAR-0215 into phase 3 development by the first quarter of 2025, pending discussions with regulatory agencies. To get STAR-0215 to market as fast as possible, Astria wants to focus 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.