Recruiting
Phase 2

BX004

Sponsor:

BiomX Ltd

Code:

NCT06998043

Conditions

Chronic Pseudomonas Aeruginosa Infection

Cystic Fibrosis (CF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BX004

Placebo

Study Details

Brief summary:

The goal of this Phase 2b clinical trial is to see if nebulized phage (BX004) can treat chronic Pseudomonas aeruginosa (PsA) lung infection in CF subjects. The primary goal is to see if 8 weeks of twice daily BX004 can reduce the amount of PsA in the sputum compared to placebo (on top of background CF therapy).

Conditions

Chronic Pseudomonas Aeruginosa Infection

Cystic Fibrosis (CF)

Study ID

NCT06998043

Start date

Jul 2, 2025

Status verified date

Jul, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

63 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BX004

Participants will be randomized to receive standard dose of nebulized bacteriophage

placebo comparator: Placebo

Participants will be randomized to receive nebulized placebo

Interventions

BX004

Bacteriophage

Placebo

Placebo

Primary outcome measure

  • Change in sputum Pseudomonas aeruginosa (PsA) burden at 8 weeks (EOT) [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Urania Rappo, MD

1-617-256-2625uraniar@biomx.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Study Coordinator

205-638-5599kathrynmonroe@uabmc.edu

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Study Coordinator

415-476-8073Legna.Betancourt@ucsf.edu

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Study Coordinator

303-270-2517wilsona@njhealth.org

Central Florida Pulmonary Group

Recruiting

Orlando, Florida, United States, 32803

Contacts

Study Coordinator

407-841-1100dserr@cfpulmonary.com

Avanza Medical Center

Recruiting

Pensacola, Florida, United States, 32503

Contacts

Study Coordinator

850-477-7900startup@avanzaresearch.com

Rutgers, Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Study Coordinator

732-235-6402warusaan@rwjms.rutgers.edu

New York Medical College

Recruiting

Hawthorne, New York, United States, 10593

Contacts

Study Coordinator

914-504-0152zachary_messer@nymc.edu

Northwell Health

Recruiting

New York, New York, United States, 10028

Contacts

Study Coordinator

212-434-4790Tdemarco3@northwell.edu

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Study Coordinator

615-343-4865valencia.bryant@vumc.org

More Information

Sponsor

BiomX Ltd

Last update posted

Jul 22, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BiomX Ltd on 2025-07-22.