Largest ever phage therapy trial shows promise for UTI treatment

Last month, researchers published the first results from the ELIMINATE clinical trial. The trial aims to test the efficacy of viruses called bacteriophages to treat urinary tract infections (UTIs). This phage therapy treatment may help when UTIs are caused by Escherichia coli bacteria resistant to antimicrobial drugs. The trial is being conducted by Locus Biosciences, and CEO Paul Garofolo says that the ELIMINATE trial is “the largest of its kind ever performed” based on enrollment data from ClinicalTrials.gov (Lancet Infect. Dis. 2024, DOI: 10.1016/S1473-3099(24)00424-9).

This part of the trial establishes a dosing regimen for a second part, which will evaluate the efficacy of treatment in up to 288 individuals. Graham Hatfull, a phage researcher at the University of Pittsburgh who was not involved in the study, says the reasons that few large clinical trials on phage therapy like this have been conducted are that manufacturing bacteriophages at scale is expensive and designing a phage cocktail with wide efficacy against multiple strains of a pathogen is difficult.

This part of the trial’s in vitro data suggest Locus’s six-strain phage cocktail is effective against 94% of the clinical E. coli isolates tested. The second part of the trial will evaluate the phage therapy’s effectiveness against currently prescribed antibiotics. Garofolo hopes that will demonstrate phage therapy’s effectiveness at treating antimicrobial resistant UTIs.