Study With Phage for CF Subjects With Pseudomonas Lung Infection

NCT06998043 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: BMX-04-002
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 14

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)

Outcome Measures

Primary Outcomes (1)

• Change in sputum Pseudomonas aeruginosa (PsA) burden at 8 weeks (EOT)

  Change from baseline in PsA colony-forming units (CFU) per g of sputum

  8 weeks

Secondary Outcomes (6)

• Change in lung function at D8, D29, D43, D57 (EOT), D85, 3 months post-dose, and 6 months post-dose

  from Day 8 until 6 months after last dose (end of study)

• Change from Baseline in CFQ-R respiratory domain

  until 6 months after last dose of study drug

• Change from Baseline in CFRSD-CRISS

  until 6 months after last dose of study drug

• Change in sputum PsA burden

  until 6 months after last dose of study drug

• Efficacy of BX004 on obtaining negative sputum cultures for PsA

  until 6 months after last dose of study drug

Study Arms (2)

BX004

EXPERIMENTAL

Participants will be randomized to receive standard dose of nebulized bacteriophage

Biological: BX004

Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive nebulized placebo

Other: Placebo

Interventions

BX004 BIOLOGICAL

Bacteriophage

Also known as: Combination of nebulized bacteriophages targeting Pseudomonas aeruginosa

BX004

Placebo OTHER

Placebo

Also known as: Nebulized placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BiomX Ltd: lead

Study Sites (14)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

NOT YET RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

NOT YET RECRUITING

Stanford University

Palo Alto, California, 94061, United States

NOT YET RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

Joe DiMaggio Children's Health

Hollywood, Florida, 33021, United States

NOT YET RECRUITING

Central Florida Pulmonary Group

Orlando, Florida, 32803, United States

RECRUITING

Avanza Medical Center

Pensacola, Florida, 32503, United States

RECRUITING

Rutgers, Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

RECRUITING

New York Medical College

Hawthorne, New York, 10593, United States

RECRUITING

Northwell Health

New York, New York, 10028, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Urania Rappo, MD

  BiomX, Inc.

  STUDY DIRECTOR

Central Study Contacts

Urania Rappo, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: May 31, 2025
• Study Start: July 2, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)