Research Triangle Park, NC – January 7, 2020 – 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. This trial is the world’s first controlled clinical trial for a recombinant bacteriophage therapy and represents a significant milestone for the field.
Locus is enrolling patients for this trial 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.
“The Locus team is excited to have started this trial,” said Paul Kim, Ph.D., Chief Development Officer of Locus. “It represents an important milestone for the company and for the field of bacteriophage therapy.”
About Urinary Tract Infections
Urinary Tract Infections (UTIs) are infections of the urinary tract, including the urethra, bladder, ureters, or kidneys and represent a significant unmet medical need as these infections can often be recurrent. These infections can be painful or irritating if limited to the bladder and can be dangerous if involving the kidneys or where the bacteria enter the bloodstream. 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.
About Bacteriophage Therapy
Bacteriophage are viruses that specifically attack bacterial cells. They are ubiquitous in the environment and are the most common organisms on the planet, outnumbering bacteria by an estimated 10 to 1. When a phage targets a bacterial cell, it injects DNA into the cell that hijacks the cell’s machinery and uses it to create new copies of itself. The infected bacterium is killed in the process of releasing tens or hundreds of new phages, which go on to infect additional bacteria. Bacteriophage have been used as antibacterial therapy since shortly after they were discovered in the early 20th century. Bacteriophage therapy has enjoyed renewed interest from the medical community in recent years as antibiotic resistance has emerged as a serious global public health threat.
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.
About the Phase 1b Trial
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.
About Locus Biosciences
Locus Biosciences is a clinical-stage biotechnology company developing CRISPR-enhanced precision antibacterial products (crPhage™) to address critical unmet medical needs in bacterial infections and microbiome indications in oncology, immunology and neuroscience therapeutic areas. The Locus platform combines CRISPR-Cas3, which shreds target DNA within a bacterial cell, with bacterial viruses called bacteriophage to specifically kill target pathogens while leaving non-target bacteria (i.e., the rest of the patient’s microbiome) unharmed.