Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection

Cystic Fibrosis Clinical Trial

Official title:

A Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects With Chronic Pseudomonas Aeruginosa (PsA) Pulmonary Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05010577
• Other study ID #: BMX-04-001
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: June 21, 2022
• Est. completion date: March 2024

Study information

• Verified date: October 2023
• Source: BiomX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1b/2a study with the primary objective to determine if BX004-A is safe and tolerable. Exploratory objectives include whether BX004-A reduces sputum Pseudomonas aeruginosa (PsA) bacterial load in CF subjects with chronic PsA pulmonary infection.

Description:

This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and tolerability of BX004-A in CF subjects with chronic PsA pulmonary infection. The study is divided into two parts, a single-ascending and multiple-dose phase (Part 1) and a multiple dose phase (Part 2). Subjects in both parts will be included in a 6-month safety follow-up. A Data Safety Monitoring Board will monitor safety in both parts. The purpose of the study is to evaluate safety and tolerability of BX004-A, and whether BX004-A reduces the PsA burden in the sputum of CF subjects with chronic PsA pulmonary infection. Clinically stable CF subjects with a confirmed diagnosis of CF and chronic PsA pulmonary infection will be enrolled.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: March 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications
• Age = 18 years
• FEV1 = 40% predicted
• Clinically stable lung disease
• Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated, induced, from home or clinic) at designated study visits.

Key Exclusion Criteria:

• Known hypersensitivity to bacteriophages or excipients in the formulation.
• Receipt of prior bacteriophage therapy within the 6 months prior to Screening
• Recovery of Burkholderia species from respiratory tract within 1 year prior to screening
• Currently receiving treatment for allergic bronchopulmonary aspergillosis
• Currently receiving treatment for active infection with non-tuberculous mycobacteria
• History of severe neutropenia
• History of lung transplant
• History of solid organ transplant
• Acquired or primary immunodeficiency syndrome
• Initiation or change in CF modulator therapy less than 3 months prior to screening
• Pregnant or breastfeeding female

Related Conditions & MeSH terms

• Communicable Diseases
• Cystic Fibrosis
• Fibrosis
• Infections
• Pseudomonas Infections

Intervention

Drug:
• BX004-A
Combination of nebulized bacteriophages targeting Pseudomonas aeruginosa
• Placebo
Nebulized placebo

Locations

Country	Name	City	State
Czechia	University Hospital in Motol	Prague
Israel	Carmel Medical Center	Haifa
Israel	Rambam Health Care Campus (RHCC) - Ruth Rappaport Children's Hospital	Haifa
Israel	Hadassah University Medical Center	Jerusalem
Israel	Schneider Children's Medical Center of Israel	Petach Tikvah
Israel	The Chaim Sheba Medical Center	Ramat Gan
Netherlands	Amsterdam Medical Center	Amsterdam
Netherlands	University Medical Center Utrecht	Utrecht
Spain	Vall d'Hebron Barcelona Hospital Campus	Barcelona
Spain	Hospital Clinico Universitario Virgen de la Arrixaca	El Palmar	Murcia
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	University Hospitals Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Florida	Gainesville	Florida
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Joe DiMaggio Children's Hospital	Hollywood	Florida
United States	Baylor College of Medicine, Texas Children Clinic	Houston	Texas
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Yale University	New Haven	Connecticut
United States	Central Florida Pulmonary Group	Orlando	Florida
United States	University of Utah	Salt Lake City	Utah
United States	Seattle Children's Hospital	Seattle	Washington
United States	New York Medical College	Valhalla	New York
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
BiomX, Inc.

Countries where clinical trial is conducted

United States,  Czechia,  Israel,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PsA burden in sputum at various timepoints	Change in PsA colony-forming units (CFU) per gram of sputum	1 month
Primary	Safety and tolerability	Incidence of treatment emergent adverse events following single and multiple doses of BX004-A administered by inhalation	6 months