American biotechnology company Locus Biosciences announced the start of patient enrollment in a Phase 1b clinical trial of the recombinant bacteriophage LBP-EC01 for urinary tract infections caused by Escherichia coli . This will be the world's first controlled clinical trial of recombinant phage therapy.

Urinary tract infections affect over 150 million people annually, with up to 90% of them caused by E. coli . Due to the spread of antibiotic-resistant E. coli strains worldwide, treatment is often challenging, leading to an active search for new, effective methods to combat the pathogen.

LBP-EC01 is a cocktail containing bacteriophages that specifically destroy E. coli . The antimicrobial properties of the bacteriophages in LBP-EC01 are enhanced by a CRISPR-Cas3 construct that damages the target bacteria's genome (these recombinant phages are called crPhage). Thus, the bacteriophages have a dual mechanism of action: natural lytic activity plus DNA-targeting CRISPR-Cas3 activity. This makes LBP-EC01 significantly more effective than corresponding natural phages, as demonstrated in laboratory experiments and animal studies.

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The developer plans to conduct a multicenter, randomized, double-blind, placebo-controlled study of the safety, tolerability, and pharmacokinetics of LBP-EC01 in patients with an indwelling urinary catheter or those requiring intermittent catheterization and/or patients with asymptomatic bacteriuria caused by E. coli . The trial plans to enroll approximately 30 adult patients. The study also aims to evaluate the pharmacodynamics of LBP-EC01 and study the drug's effect on the urinary tract microbiota. The developer has already received approval for Phase 1b clinical trials from the FDA (more information about the trial: https://clinicaltrials.gov/ct2/show/NCT04191148 ).