Astria Therapeutics, Inc. announced on October 2, 2025, that it has begun opening clinical trial sites and screening participants in the European Union (EU) for the Phase 3 ALPHA-ORBIT trial of navenibart. Navenibart is an investigational monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of hereditary angioedema (HAE).
The European Medicines Agency (EMA) has approved the activation of an anticipated 32 sites across 10 EU countries, including Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, and Spain. This expansion significantly broadens the global reach of the ALPHA-ORBIT trial, which is already enrolling patients in the United States, United Kingdom, Canada, Hong Kong, South Africa, Japan, North Macedonia, and Israel.
The ALPHA-ORBIT trial is a global, randomized, double-blind, placebo-controlled pivotal study designed to evaluate the efficacy and safety of navenibart administered every 3 months or every 6 months. Expanding enrollment into the EU is expected to accelerate patient recruitment and underscores navenibart's potential to provide rapid and sustained HAE attack prevention with a low treatment burden for patients worldwide.
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