Locus Biosciences announced today 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 (E. coli) bacteria causing urinary tract infections (UTIs). As the world’s first controlled clinical trial for a recombinant bacteriophage therapy this trial represents a significant milestone for the field.
Worldwide, 150 million people are affected by UTIs each year, with 80-90% of these caused by E. coli, sometimes including difficult-to-treat strains that are resistant to commonly used antibiotics. The need for new antibacterial therapies is widely recognized, particularly therapies that selectively kill target bacteria while leaving the many species of good bacteria in the body unharmed.
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.
Locus is enrolling patients for the Phase 1b clinical trial evaluating LBP-EC01 across several clinical sites in the United States. The company received clearance from the United States Food and Drug Administration (FDA) for its Investigational New Drug (IND) application in Q4 2019 and began activating its study sites shortly thereafter.
“This trial represents a major step toward proving that CRISPR recombinant phage can reach into the human body and precisely remove a specific pathogen,”
said Paul Garofolo, Chief Executive Officer of Locus.
“We could not be more pleased with the team and partners who helped us advance from bold vision to the clinic.”
About the Phase 1b Trial
Study LBx-1001 is a multi-center randomized, double-blind, placebo-controlled 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.