Astria Therapeutics initiates ALPHA-ORBIT Phase 3 pivotal trial of navenibart in hereditary angioedema

Astra Therapeutics 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 (Q3M) and every 6 months (Q6M).

Christopher Morabito MD, Chief Medical Officer at Astria Therapeutics, said: “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. 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.”

Dr Aleena Banerji, Clinical Director MGH Allergy and Immunology Unit, and a Principal Investigator for the ALPHA-ORBIT trial, said: “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. 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.”

ALPHA-ORBIT is a global, randomized, double-blind, placebo-controlled Phase 3 pivotal clinical trial to evaluate the efficacy and safety of navenibart over a 6-month treatment period in up to 135 adults and 10 adolescents (open label), with HAE Type 1 or Type 2. Adult patients will be randomized to receive one of three navenibart dose arms:

  • An initial 600mg dose followed by 300mg Q3M
  • 600mg Q6M
  • 600mg Q3M, or placebo; adolescents will receive an initial 600mg dose followed by 300mg Q3M

The dose arms support the potential to provide patient-centered dosing flexibility to people with HAE. The primary endpoint is time-normalized monthly HAE attacks at 6 months, and a key secondary endpoint includes the proportion of participants who are attack-free at 6 months. Top-line results from the trial are anticipated in early 2027.

(Source: Astria)