Study investigating Phage therapy to treat Pseudomonas lung infection in people with Cystic Fibrosis

Full title

Study to Evaluate a Nebulised Bacteriophage Treatment in Adults with Cystic Fibrosis (CF) with Chronic Pseudomonas aeruginosa (PsA) Pulmonary Infection

Study details

The sponsor has announced the discontinuation of this study due to a higher-than-expected rate of adverse events. If you would like to discuss this further, please contact your CF care team.

The aim of this Phase 2b study is to further assess the safety and effectiveness of a new nebulised phage (BX004) medicine for the treatment of chronic Psuedomonas aeruginosa (PsA) lung infection in people with CF. The end goal is to see if after BX004 treatment the amount of PsA in sputum samples has decreased. 

BX004 contains five natural bacteriophages. A bacteriophage is a type of virus that only infects and kills specific bacteria and does not harm or infect human cells. Bacteriophages specific for PsA could be a good treatment for people with CF who have a long-lasting infection in their lungs from PsA. 

In this study, participants will be randomly assigned to receive either BX004 or placebo. Participants will have a 66% (2 in 3) chance of getting BX004, and 33% (1 in 3) chance of getting placebo. 

All participants will receive either BX004 or placebo twice daily for 8 weeks in addition to your usual CF therapy (including inhaled antibiotic for PsA, if you are taking one). 

The total length of participation is approximately 36 weeks (9 months) including around 9 in-person study visits, across the following periods: 

• Screening Period: first visit (1 visit, period is up to 28 days)
• Study Treatment Period (5 visits across 8 weeks/2months)
• Follow-Up Period: after the last dose of BMX004 (3 visits across 24 weeks/6months)

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