BOSTON– Astria Therapeutics, Inc. (Nasdaq: ATXS), a biopharmaceutical company advancing therapies for allergic and immunologic diseases, announced today that it has started opening clinical trial sites in the European Union for the Phase 3 ALPHA-ORBIT trial of navenibart. The investigational monoclonal antibody targets plasma kallikrein and is being developed as a potential treatment for hereditary angioedema (HAE), with dosing options as infrequent as every 3 to 6 months.
With regulatory approval from the European Medicines Agency (EMA), Astria plans to activate 32 clinical sites across 10 EU countries—Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, and Spain. The ALPHA-ORBIT trial is already enrolling patients across the United States, Europe, the United Kingdom, Canada, Hong Kong, South Africa, Japan, North Macedonia, and Israel.
“We’re thrilled to be enrolling eligible participants in the EU for the Phase 3 ALPHA-ORBIT trial,” said Christopher Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “The excitement we’re seeing from physicians and patients in the EU underscores navenibart’s potential to change the way people live with HAE across the globe.”
“Navenibart’s profile is compelling for people living with HAE, and we are thrilled that HAE patients in Europe now have the opportunity to enroll in the ALPHA-ORBIT trial,” said Danny Cohn, M.D., Ph.D., Head of the HAE Center of Expertise at Amsterdam UMC, Amsterdam, the Netherlands. “We encourage patients to work with their physician to learn more about the ALPHA-ORBIT trial and navenibart.”
“People living with HAE are waiting; not just for treatments that reduce the burden of disease, but for those that also ease the burden of treatment,” said Maria Kortekaas, President of HAE Netherlands. “Clinical trials are part of the promise of progress, and we are pleased that Astria has chosen to conduct this late-stage trial in numerous countries throughout Europe.”
The ALPHA-ORBIT study is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of navenibart administered every 3 or 6 months. Up to 135 adults and 10 adolescents with HAE Type 1 or Type 2 are expected to enroll. The primary endpoint is time-normalized monthly HAE attack rate at 6 months, with a key secondary endpoint being the percentage of participants who remain attack-free over the same period.
Participants completing the ALPHA-ORBIT trial may be eligible to join ORBIT-EXPANSE, a long-term extension study in which all patients receive navenibart with a flexible, patient-centered dosing schedule. Both studies are part of the broader Phase 3 program designed to support global regulatory submissions.
