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

Purpose

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.

Conditions

  • Chronic Pseudomonas Aeruginosa Infection
  • Cystic Fibrosis

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BX004-A 		Participants will be randomized to receive standard dose of nebulized bacteriophage
  • Drug: BX004-A
    Combination of nebulized bacteriophages targeting Pseudomonas aeruginosa
    Other names:
    • Bacteriophage
Placebo Comparator
Placebo 		Participants will be randomized to receive nebulized placebo
  • Drug: Placebo
    Nebulized placebo
    Other names:
    • Vehicle buffer

Recruiting Locations

More Details

NCT ID
NCT05010577
Status
Active, not recruiting
Sponsor
BiomX, Inc.

Detailed 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.