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

Pseudomonas Aeruginosa Clinical Trial

— Tailwind  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05616221
• Other study ID #: AP-PA02-201
• Status: Recruiting
• Phase: Phase 2
• Start date: January 10, 2023
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Armata Pharmaceuticals, Inc.
• Contact: Pierre Kyme, PhD
• Phone: 310-665-2928
• Email: pkyme[@]armatapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 a1-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

Related Conditions & MeSH terms

• Bronchiectasis
• Communicable Diseases
• Fibrosis
• Infections
• Lung Infection
• Non-cystic Fibrosis Bronchiectasis
• Pseudomonas Aeruginosa
• Pseudomonas Infections

Intervention

Biological:
• AP-PA02
Bacteriophage administered via inhalation

Other:
• Placebo
Inactive Placebo administered via inhalation

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	St. Lukes Hospital	Boise	Idaho
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Cincinnati - College of Medicine	Cincinnati	Ohio
United States	University Hospitals of Cleveland Medical Center	Cleveland	Ohio
United States	UCONN Health	Farmington	Connecticut
United States	Southwest General Healthcare Center	Fort Myers	Florida
United States	New York Medical College	Hawthorne	New York
United States	TecTum Medical Research, Inc.	Hollywood	Florida
United States	Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine	Jacksonville	Florida
United States	The University of Kansas Medical Center / Dept of Medicine	Kansas City	Kansas
United States	Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Velocity Clinical Research	Mobile	Alabama
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	University of Pennslyvania	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Virginia Commonwealth University (VCU)	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Washington Medical Center	Seattle	Washington
United States	University of Texas Health Science Center at Tyler	Tyler	Texas
United States	Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Armata Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Armata Pharmaceuticals, Inc.