Tailwind: 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

Sponsor

Armata Pharmaceuticals, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05616221

Collaborator

(none)

Enrollment

Locations

Arms

12.7

Anticipated Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non-cystic Fibrosis Bronchiectasis Pseudomonas Aeruginosa Lung Infection	Biological: AP-PA02 Other: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double-blind, randomized, placebo-controlledDouble-blind, randomized, placebo-controlled

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 10, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

P. aeruginosa recovery in sputum following multiple doses of AP-PA02 administered by inhalation [Day 1 pre-dose through 7 days post last dose of study drug]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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