Nebulized phage (BX004) treatment for adults with CF and chronic Pseudomonas lung infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• National Jewish Health
  Denver, Colorado, United States 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

Study contacts

• Study coordinator: Urania Rappo, MD
• Email: uraniar@biomx.com
• Phone: 1-617-256-2625

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.