Astria initiates ALPHA-ORBIT Phase 3 trial of navenibart for HAE treatment

Astria Therapeutics (ATXS) announced the initiation of the ALPHA-ORBIT Phase 3 clinical trial of navenibart in people living with hereditary angioedema HAE . Navenibart has the potential to provide rapid and sustained HAE attack prevention with a very low treatment burden and administration every 3 months and every 6 months Q6M. “We believe that navenibart will deliver strong efficacy, low treatment burden, and favorable safety and tolerability and we are thrilled to have initiated our Phase 3 ALPHA-ORBIT trial to support that vision,” said Christopher Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “The Phase 3 program is designed to enable options, providing patients and physicians with the potential to decide what works best for them by administering navenibart only 2 or 4 times per year.” “We understand from patients that it would be incredibly meaningful to have a therapy that would enable them to live their lives free from the limitations of HAE,” said Dr. Aleena Banerji, Clinical Director MGH Allergy and Immunology Unit, and a Principal Investigator for the ALPHA-ORBIT trial. “Navenibart has demonstrated the potential to prevent HAE attacks with infrequent dosing, which could allow patients the freedom to spend less time managing their disease.”