Armata Pharmaceuticals Completes Enrollment for Phase 2 Tailwind Study of Inhaled AP-PA02 in Non-Cystic Fibrosis Bronchiectasis with Chronic Pulmonary Pseudomonas Infection

Armata Pharmaceuticals, Inc., a biotechnology firm focusing on bacteriophage therapeutics for antibiotic-resistant and hard-to-treat bacterial infections, announced the full enrollment of its Tailwind Phase 2 clinical trial. This study evaluates inhaled AP-PA02 in patients with non-cystic fibrosis bronchiectasis (NCFB) and chronic pulmonary Pseudomonas aeruginosa infections. The final follow-up visit for the last patient is slated for August 7, 2024, with topline data expected in the latter half of 2024.

Dr. Deborah Birx, CEO of Armata, expressed satisfaction with the enrollment process, citing that it aligns well with their internal timelines. She emphasized the ongoing collection of evidence supporting phage therapy for chronic bacterial respiratory infections. The study involves two cohorts: one without prior or current inhaled antibiotics undergoing phage-only treatment compared to a placebo, and another receiving both inhaled phage and antibiotics. Dr. Birx anticipates sharing topline data soon and plans to discuss a pivotal Phase 3 study with the FDA, which is targeted to commence in 2025. She underscored Armata's commitment to conducting rigorously designed randomized trials to support the registration of their phage candidates.

Mina Pastagia, Chief Medical Officer, highlighted that the successful outcomes of the SWARM-P.a. study of inhaled AP-PA02 in cystic fibrosis patients provided valuable insights for the Tailwind trial's design. The Tailwind study features an optimized dosing regimen, aiming to establish both the clinical safety and the efficacy of reducing P. aeruginosa in the lungs. Pastagia expressed confidence in demonstrating these outcomes and emphasized the urgent need for pathogen-specific anti-infectives for patients suffering from bronchiectasis and chronic P. aeruginosa infections.

The Tailwind study is structured as a Phase 2, multi-center, double-blind, randomized, placebo-controlled trial. It examines the safety, tolerability, and effectiveness of inhaled AP-PA02 both as a monotherapy and in combination with inhaled antibiotics for subjects with NCFB and chronic pulmonary P. aeruginosa infection. The primary endpoint is the recovery of P. aeruginosa from sputum after multiple doses of the inhaled treatment.

Armata Pharmaceuticals is at the forefront of developing bacteriophage-based therapeutics aimed at treating antibiotic-resistant and difficult-to-treat bacterial infections. Their pipeline includes both natural and synthetic phage candidates targeting pathogens such as Pseudomonas aeruginosa and Staphylococcus aureus. The company is dedicated to advancing phage therapy from the bench to clinical settings, including in-house GMP manufacturing capabilities.

This milestone in the Tailwind Phase 2 study reflects Armata's broader commitment to addressing chronic bacterial infections through innovative phage therapies. The upcoming data release and planned pivotal Phase 3 trial represent significant steps towards potentially new treatment options for patients with bronchiectasis and chronic pulmonary infections caused by P. aeruginosa.