Phase 2b Randomized, Double-Blind Study with Phage for CF Subjects with Pseudomonas Lung Infection
Research type
Research Study
Full title
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
IRAS ID
1011712
Contact name
Myriam Golembo
Contact email
Sponsor organisation
BiomX Ltd.
Research summary
The study aims to assess the efficacy of a nebulised bacteriophage treatment called BX004 for the treatment of chronic Pseudomonas aeruginosa (PsA) pulmonary infection in patients with cystic fibrosis (CF). It will evaluate the efficacy and tolerability of nebulised BX004 on sputum PsA burden in CF patients by comparing it to a placebo. The study will enrol individuals regardless of whether they are receiving inhaled anti-pseudomonal antibiotics for chronic suppression of PsA. BX004 is intended for aerosolised administration and is a fixed, pre-mixed formulation comprising five natural bacteriophages with activity against a broad range of PsA isolates obtained from CF patients. The product is supplied in one vial. The drug is administered by nebulisation using a nebuliser provided by the Sponsor. Each nebulisation lasts approximately 10 minutes. This study is a phase 2b, randomised, double blind, placebo controlled trial. Participants will be randomised to the treatment arms and will receive BX004 or placebo treatment twice daily for 8 weeks. During the study, participants will visit the study site about 12 times over an estimated 8 months. Once the treatment is complete, periodic follow-up visits will occur at 1-month, 3-months and 6-months after last dose. The following study procedures will be performed: (a) targeted lung exams; (b) sputum collection; (c) blood tests; (d) urine tests (if female of child-bearing potential); (e) lung function tests; (f) nebulising, and (g) questionnaires.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
25/EM/0102
Date of REC Opinion
6 Jun 2025
REC opinion
Further Information Favourable Opinion