Astria Therapeutics announces design of ALPHA-ORBIT pivotal Phase 3 trial of navenibart in HAE
Astra Therapeutics has announced its planned design of the ALPHA-ORBIT Phase 3 clinical trial of navenibart in people with HAE, which will include both every 3- (Q3M) and every 6-month (Q6M) treatment arms with the primary analysis at 6 months.
Global start-up activities are underway, and ALPHA-ORBIT is expected to initiate in Q1 2025, with top-line results anticipated in early 2027.
Jill C Milne, PhD, Chief Executive Officer at Astria, said: “We are thrilled to announce our planned Phase 3 design, which reflects feedback from regulators and is intended to support global registration for both Q3M and Q6M administration. With navenibart, we are pioneering patient-centric dosing flexibility in HAE with the goal of maximizing attack rate reduction with a compellingly low burden of treatment.”
Christopher Morabito, MD, Chief Medical Officer at Astria, said: “Our Phase 3 program was designed in collaboration with the patient community and physicians, is based on input from global regulatory authorities, and addresses the importance of providing options to patients for a disease that’s highly variable. Phase 3 preparations are underway, with trial initiation on-track and expected for this quarter. We are driven by the goal of bringing a potentially life-changing therapy to patients with HAE.”
ALPHA-ORBIT is designed as 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 145 patients with Type 1 or Type 2 HAE. Patients will be randomized to receive one of three navenibart dose arms: 1) an initial 600 mg dose and followed by 300 mg Q3M, 2) 600 mg Q6M, and 3) 600 mg Q3M, or placebo. The dose arms support the potential to provide patient-centric 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. After 6 months, patients may be eligible to enter a long-term extension trial, in which all patients will be treated with navenibart (open-label) and which will include an open-label, patient-centric flexible dosing period. The navenibart Phase 3 program will consist of the ALPHA-ORBIT Phase 3 trial and the long-term extension trial, which are designed to support registration globally. The Phase 3 program was designed with input from the European Medicines Agency and the Company’s end of Phase 2 meeting with the US Food and Drug Administration (FDA) held in December 2024.
(Source: Astria)