Astria Opens EU Sites For Phase 3 ALPHA-ORBIT Trial Of Navenibart In Hereditary Angioedema

Astria Therapeutics, Inc., a biopharmaceutical company focused on developing therapies for allergic and immunologic diseases, announced the opening of clinical trial sites in the European Union (EU) for the Phase 3 ALPHA-ORBIT trial of navenibart. Navenibart is an investigational monoclonal antibody that inhibits plasma kallikrein and is being developed for the treatment of hereditary angioedema (HAE), with the potential for dosing every 3 to 6 months. The company expects to begin screening EU participants shortly.

“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.”

The ALPHA-ORBIT trial is a global, randomized, double-blind, placebo-controlled Phase 3 pivotal study enrolling up to 135 adults and 10 adolescents with HAE Type 1 or Type 2. Clinical sites are active in the U.S., Europe, United Kingdom, Canada, Hong Kong, South Africa, Japan, North Macedonia, and Israel. EMA approval has enabled the activation of 32 trial sites across 10 EU countries: Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, and Spain. The trial’s primary endpoint is reduction in time-normalized monthly HAE attacks at 6 months, with a key secondary endpoint measuring the proportion of participants who remain attack-free.

“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.”

Astria’s navenibart Phase 3 program includes both ALPHA-ORBIT and the ORBIT-EXPANSE long-term trial, designed to support global registration. After completing 6 months in ALPHA-ORBIT, participants may transition into ORBIT-EXPANSE, where all patients will receive navenibart with access to a patient-centered flexible dosing schedule. This approach aims to address the significant unmet need for long-lasting and convenient treatment options for HAE.

“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, a non-profit organization. “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.”