Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection (Tailwind)

A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 Multi-Phage Therapeutic in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection

A phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 administered in subjects with non-cystic fibrosis bronchiectasis and chronic pulmonary Pseudomonas aeruginosa infection.

Study Overview

• Status: Completed
• Conditions: Pseudomonas Aeruginosa; Lung Infection; Non-cystic Fibrosis Bronchiectasis
• Intervention / Treatment: Biological: AP-PA02; Other: Placebo

Detailed Description

This study will be conducted in two cohorts running in parallel: Cohort A will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have not received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior. Cohort B will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior. Subjects in both Cohorts A and B will be followed for approximately 4 weeks after last dose of study drug and evaluated for safety, tolerability, and efficacy.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Velocity Clinical Research
  • California
    • Los Angeles, California, United States, 90048
      • Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • UConn Health
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine
  • Florida
    • Fort Myers, Florida, United States, 33907
      • Southwest General Healthcare Center
    • Hollywood, Florida, United States, 33024
      • TecTum Medical Research, Inc.
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine
    • Miami, Florida, United States, 33146
      • University of Miami
  • Idaho
    • Boise, Idaho, United States, 83702
      • St. Lukes Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center / Dept of Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University School of Medicine
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Robert Wood Johnson Medical School
  • New York
    • Hawthorne, New York, United States, 10595
      • New York Medical College
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati - College of Medicine
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennslyvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center
  • Texas
    • Tyler, Texas, United States, 75708
      • University of Texas Health Science Center at Tyler
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University (VCU)
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• ≥ 18 years old
• Body mass index (BMI) of ≥ 18 kg/m2
• Evidence of bronchiectasis per CT
• Evidence of chronic pulmonary Pseudomonas aeruginosa infection
• Willing to undergo sputum induction procedures at designated study visits, and willing to provide expectorated sputum samples at all other timepoints (for subjects who are able to expectorate)
• FEV1 ≥ 35% of predicted normal [per Global Lung Function Initiative (GLI) standards] at Screening
• For Cohort A: have not received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1
• For Cohort B: have received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1

Key Exclusion Criteria:

• Abnormal vital signs at Screening
• History of lung transplantation
• History of cystic fibrosis
• History of α1-antitrypsin deficiency
• History of primary or acquired immunodeficiency syndromes
• History of COPD
• History of pulmonary malignancy or any other malignancy requiring treatment
• History of prolonged QT syndrome
• History of hemoptysis
• Recent significant weight loss
• Recent use of supplemental oxygen during the day while at rest
• Recent use of cigarettes, cigars, or pipes, or used tobacco or other nicotine source by vaping
• Recent changes in either the treatment regimen or initiation of treatment with: oral macrolides, hypertonic saline, mucolytics, bronchodilator medications, or oral corticosteroids
• Currently receiving treatment for active infection at any site
• Female pregnant of breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AP-PA02; Anti-pseudomonal bacteriophage	Biological: AP-PA02; Bacteriophage administered via inhalation
Placebo Comparator: Placebo; Inactive isotonic solution	Other: Placebo; Inactive Placebo administered via inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
P. Aeruginosa Recovery in Sputum Following Multiple Doses of AP-PA02 Administered by Inhalation	Change from baseline in P. Aeruginosa density (colony forming units) as measured in induced sputum samples one week after end of treatment.	Day 17

Collaborators and Investigators

• Sponsor: Armata Pharmaceuticals, Inc.
• Investigators: Study Director: Mina Pastagia, MD, Armata Pharmaceuticals, Inc.

Publications and helpful links

Helpful Links

• Armata Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): July 17, 2024
• Study Completion (Actual): August 8, 2024

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Bacteriophage; Phage; Pseudomonas Aeruginosa; BE; Pseudomonas; NCFB
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Pseudomonas Infections
• Other Study ID Numbers: AP-PA02-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No