Astria Therapeutics has commenced the Phase III ORBIT-EXPANSE long-term study evaluating navenibart (STAR-0215) in individuals with hereditary angioedema (HAE).
The Phase III programme of navenibart comprises the ORBIT-EXPANSE long-term study and the ALPHA-ORBIT Phase III trial, both aimed at facilitating global registration.
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Upon completion of the ALPHA-ORBIT study, eligible subjects may transition into the ORBIT-EXPANSE study, where all subjects will receive navenibart in either quarterly or biannual regimens.
Astria Therapeutics chief medical officer Christopher Morabito said: “The initiation of ORBIT-EXPANSE marks exciting progress in the development of navenibart.
“The entrance of eligible and interested participants into the ORBIT-EXPANSE long-term trial following the completion of the pivotal Phase III ALPHA-ORBIT trial highlights enthusiasm for navenibart, and we are deeply grateful to trial participants and site facilitators for their continued partnership.”
In the study’s first part, subjects will be administered navenibart according to a fixed dosing regimen for a minimum of six months.
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By GlobalDataSubjects in the second part may transition between different regimens based on their individual requirements during a subject-centred flexible dosing period.
Navenibart is a monoclonal antibody that inhibits plasma kallikrein and is currently under development for HAE. It is administered subcutaneously every three to six months.
The company aims to offer rapid and sustained prevention of HAE attacks through a validated mechanism with navenibart.
Astria Therapeutics develops therapies for families and patients impacted by immunologic and allergic diseases.
The company’s second programme, STAR-0310, is an investigational monoclonal antibody OX40 antagonist currently in clinical development for atopic dermatitis treatment.
In June 2025, Astria reported encouraging initial outcomes from its ALPHA-SOLAR trial of navenibart in patients with HAE.
