New long-term trial of potential HAE treatment initiated

A new long-term trial of the potential HAE treatment navenibart has begun. The trial, called ORBIT-EXPANSE is a Phase-3, long-term trial of navenibart in people living with hereditary angioedema (HAE).

Christopher Morabito, MD, Chief Medical Officer at Astria Therapeutics, 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 3 ALPHA-ORBIT trial highlights enthusiasm for navenibart, and we are deeply grateful to trial participants and site facilitators for their continued partnership.”

The navenibart Phase-3 program consists of the ALPHA-ORBIT Phase 3 trial and ORBIT-EXPANSE long-term trial, which are designed to support registration globally. After completing ALPHA-ORBIT, eligible participants may continue into the ORBIT-EXPANSE trial, in which all participants will receive navenibart in either three-month or six-month regimens. The trial has two parts: in Part 1, participants will receive navenibart in a fixed dosing regimen for at least six months, and, in Part 2, participants may move from one regimen to another based on their needs via a patient-centered flexible dosing period.

(Source: Astria)