Armata Pharmaceuticals has completed patient enrollment for its Phase II Tailwind study for inhaled bacteriophage therapy AP-PA02, targeting chronic pulmonary Pseudomonas infections.
The Tailwind study is a pivotal trial that aims to assess the safety, tolerability, and efficacy of AP-PA02 therapy in subjects with non-cystic fibrosis bronchiectasis (NCFB) and chronic pulmonary Pseudomonas aeruginosa (P aeruginosa) infection.
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The last patient follow-up is scheduled for 7 August 2024.
Armata anticipates the topline data from the trial in the second half of 2024.
Armata CEO Dr Deborah Birx said: “In this study, we enrolled a cohort of patients without prior or current inhaled antibiotics, allowing for the evaluation of phage-only therapy compared to placebo, in addition to a cohort of patients receiving inhaled phage plus antibiotics.
“We look forward to sharing topline data as soon as it becomes available and plan to meet with the FDA shortly thereafter on the design of a pivotal Phase III study, which we are planning to initiate in 2025.
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By GlobalData“We remain committed to the execution of rigorously designed randomised trials that, if successful, will support registration of our phage candidates.”
The study’s primary endpoint is the reduction of P aeruginosa in sputum after multiple AP-PA02 doses administered via inhalation.
Planned across multiple centres, the study is a randomised, double-blind, placebo-controlled trial intended to assess the safety, tolerability, and efficacy of inhaled AP-PA02 as both a monotherapy and in conjunction with inhaled antibiotics.
Armata chief medical officer Mina Pastagia said: “Notably, the Tailwind study includes an optimised dosing regimen that gives us confidence in our ability to demonstrate clinical safety while evaluating the durability of P aeruginosa reduction in the lungs.”
