Nebulized phage (BX004) treatment for adults with CF and chronic Pseudomonas lung infection
A Phase 2b, 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
This trial will test whether inhaled phage therapy (BX004), given twice daily for 8 weeks, can reduce Pseudomonas aeruginosa in the sputum of adults with cystic fibrosis and chronic lung infection.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BiomX, Inc. Industry-sponsored |
| Locations | 14 sites (Birmingham, Alabama and 13 other locations) |
| Trial ID | NCT06998043 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled, multicenter Phase 2b study comparing nebulized BX004 versus placebo in clinically stable adults with cystic fibrosis and chronic Pseudomonas aeruginosa pulmonary infection. Participants receive twice-daily nebulized dosing for 8 weeks on top of their background CF therapies, with sputum samples collected to measure bacterial burden. Primary outcome is change in PsA amount in sputum; secondary outcomes include lung function, quality of life, rates of negative sputum cultures, and safety/tolerability. Subjects are followed for safety for 6 months after dosing, with oversight by a CF Foundation Data Safety Monitoring Board.
Who should consider this trial
Good fit: Adults (≥18 years) with confirmed cystic fibrosis and chronic Pseudomonas aeruginosa pulmonary infection who are clinically stable, have FEV1 40–80% predicted, and can provide adequate sputum samples are ideal candidates.
Not a fit: Patients under 18, those with FEV1 below 40% predicted, known hypersensitivity to bacteriophages or formulation components, recent phage therapy, or recent detection of Burkholderia cenocepacia or active nontuberculous mycobacterial infection are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, BX004 could offer a new inhaled option to lower Pseudomonas levels in the lungs, potentially improving breathing, quality of life, and reducing reliance on systemic antibiotics.
How similar studies have performed: Phage therapy for Pseudomonas has shown promise in case reports and small compassionate-use series, but randomized controlled data are limited and this approach remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care inhaled antibiotics (cycling or continuous regimen) or no inhaled antibiotics * Age ≥ 18 years * FEV1 40%-80% 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 or Day 1 * Detection of Burkholderia cenocepacia from respiratory tract within 1 year prior to Screening or from Screening culture * Currently receiving systemic treatment for allergic bronchopulmonary aspergillosis * Currently receiving treatment for active infection with non-tuberculous mycobacteria or prior detection of Mycobacterium abscessus in 12 months prior to Screening * History of severe neutropenia * History of lung transplant * History of solid organ transplant * Acquired or primary immunodeficiency syndrome * Initiation or change in type of CFTR modulator less than 3 months prior to Screening * Pregnant or breastfeeding female
Where this trial is running
Birmingham, Alabama and 13 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Providence Alaska Medical Center — Anchorage, Alaska, United States (Not_yet_recruiting)
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Not_yet_recruiting)
- Stanford University — Palo Alto, California, United States (Not_yet_recruiting)
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- National Jewish Health — Denver, Colorado, United States (Recruiting)
- Joe DiMaggio Children's Health — Hollywood, Florida, United States (Not_yet_recruiting)
- Central Florida Pulmonary Group — Orlando, Florida, United States (Recruiting)
- Avanza Medical Center — Pensacola, Florida, United States (Recruiting)
- Rutgers, Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (Recruiting)
- New York Medical College — Hawthorne, New York, United States (Recruiting)
- Northwell Health — New York, New York, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Urania Rappo, MD
- Email: uraniar@biomx.com
- Phone: 1-617-256-2625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.