Armata Pharmaceuticals, Inc. announced encouraging topline results from its Phase 2 ("Tailwind") trial evaluating AP-PA02, a novel, inhaled multi-phage therapeutic for the treatment of chronic pulmonary Pseudomonas aeruginosa ("P.a." or "P. aeruginosa") infections in non-cystic fibrosis bronchiectasis ("NCFB") patients. This is the second successful clinical trial AP-PA02, Armata's lead pulmonary candidate, which was first evaluated in cystic fibrosis patients in the Phase 1b/2a SWARM-P.a. trial, completed in 2023. The Tailwind study (NCT05616221) was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated the safety, pharmacokinetics and efficacy of inhaled AP-PA02.
The Tailwind study was conducted in two cohorts running in parallel: subjects in one cohort (cohort A) received inhaled AP-PA02 as monotherapy, while subjects in another cohort (cohort B) received inhaled anti-pseudomonal antibiotic treatment. The study data indicate the potential for phage therapy to reduce reliance on chronic antibiotic use. Safety data indicate that inhaled AP-PA02 was well-tolerated with treatment-emergent adverse events mild and self-limiting.
The company believe the safety and tolerability of AP-PA02 exhibited a promising profile for treating chronically infected NCFB patients.