What's Happening?
Astria Therapeutics has started enrolling hereditary angioedema (HAE) patients in the European Union for its Phase 3 ALPHA-ORBIT trial. The trial will evaluate navenibart, an investigational monoclonal antibody inhibitor of plasma kallikrein, for HAE treatment. The trial is approved by the European Medicines Agency and will involve 32 sites across 10 EU countries. Astria aims to provide rapid and sustained HAE attack prevention with navenibart, administered every 3 and 6 months.
Why It's Important?
The ALPHA-ORBIT trial represents a significant advancement in HAE treatment, offering potential improvements in disease management and quality of life for patients. Navenibart's dosing schedule could reduce the burden of treatment, addressing a major need in the HAE community. The trial's global reach underscores Astria's commitment to developing therapies that empower patients to live without limitations from their disease.
What's Next?
Following the ALPHA-ORBIT trial, patients may enter the ORBIT-EXPANSE long-term trial, where all participants will receive navenibart. Astria plans to continue expanding its clinical trial network and collaborate with healthcare providers to ensure successful trial enrollment. Positive trial outcomes could lead to regulatory approval and broader access to navenibart for HAE patients worldwide.
