The company expects the topline data from the trial in the later half of 2024. Credit: Orawan Pattarawimonchai/Shutterstock. 

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.  

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“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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“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.”