Astria Therapeutics has commenced the randomised, placebo-controlled ALPHA-ORBIT Phase III trial of navenibart to treat individuals with hereditary angioedema (HAE).
The global, double-blind trial is designed to assess the safety and efficacy of the therapy over six months.
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It will evaluate navenibart in up to 135 adults and ten adolescents with HAE type 1 or type 2. Adult subjects will be administered with one of three therapy dosing regimens or a placebo in the different treatment arms.
The initial arm will involve a 600mg dose of the therapy, followed by 300mg every three months (Q3M). The second arm will involve a 600mg dose every six months, and the last arm will use 600mg given Q3M.
Adolescent subjects of the trial will be given a specific dosing schedule involving 600mg initially, followed by 300mg given Q3M.
The trial’s primary endpoint is the time-normalised monthly rate of HAE attacks at the six-month mark.
A key secondary endpoint is the proportion of subjects who remain attack-free during the six-month period. Top-line outcomes are expected to be released in early 2027.
Following this duration, eligible subjects may proceed to the ORBIT-EXPANSE long-term trial, which offers a ‘patient-centred’ flexible dosing period and includes all of the therapy-treated subjects.
The ALPHA-ORBIT and ORBIT-EXPANSE trials are part of the Phase III programme for navenibart, aiming to support its worldwide registration.
Astria Therapeutics chief medical officer Christopher Morabito said: “We believe that navenibart will deliver strong efficacy, low treatment burden, and favourable safety and tolerability, and we are thrilled to have initiated our Phase III ALPHA-ORBIT trial to support that vision.”
The decision to advance to Phase III trials was based on the promising final top-line results from the Phase Ib/II ALPHA-STAR trial.
Through navenibart, Astria aims to provide a quick and ‘sustained’ method for preventing HAE attacks, using a validated mechanism and an established modality, with the flexibility of administration every three or six months.
In February 2023, the company announced the commencement of the Phase Ib/II ALPHA-STAR trial of STAR-0215 to treat HAE patients.
