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The first controlled clinical trial for a CRISPR enhanced phage therapy was initiated

 

Locus Biosciences announced that it has opened for enrollment a Phase 1b clinical trial evaluating LBP-EC01, a CRISPR Cas3-enhanced bacteriophage (crPhage™) product that will target Escherichia coli bacteria causing urinary tract infections. This trial is the world’s first controlled clinical trial for a recombinant bacteriophage therapy and represents a significant milestone for the field.

LBP-EC01 is a bacteriophage cocktail that has been engineered with a CRISPR-Cas3 construct targeting the E. coli genome. The product works through a unique dual mechanism of action utilizing both the natural lytic activity of the bacteriophage along with the DNA-targeting activity of CRISPR-Cas3. This dual mechanism makes LBP-EC01 significantly more effective at killing E. coli cells than corresponding natural bacteriophages, as shown both in laboratory tests and in small animal models of urinary tract infection.

Study LBx-1001 is a multi-center randomized, double-blind study to assess the safety, tolerability, and pharmacokinetics of LBP-EC01 in patients with indwelling urinary catheters, or requiring intermittent catheterization, and/or patients with asymptomatic bacteriuria caused by E. coli. Approximately 30 adult patients will be enrolled. The study will have a secondary objective to evaluate the pharmacodynamics of LBP-EC01 and an exploratory objective to explore the influence of LBP-EC01 on the urinary tract microbiota. Additional information on the trial can be found at https://clinicaltrials.gov/ct2/show/NCT04191148.