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)

Armata Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Lung Infection; Non-cystic Fibrosis Bronchiectasis; Pseudomonas Aeruginosa

Treatments: Other: Placebo; Biological: AP-PA02

Study type: Interventional

Funder types: Industry

Identifiers

NCT05616221

AP-PA02-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

AP-PA02

Experimental group

Description:

Anti-pseudomonal bacteriophage

Treatment:

Biological: AP-PA02

Placebo

Placebo Comparator group

Description:

Inactive isotonic solution

Treatment:

Other: Placebo