Phase 1b trial demonstrates that the company’s lead precision medicine asset is safe and well tolerated
RESEARCH TRIANGLE PARK, N.C., Feb. 24, 2021 (GLOBE NEWSWIRE) — Locus Biosciences, a clinical-stage biotechnology company, announced today the completion of its Phase 1b clinical trial of LBP-EC01, a CRISPR-Cas3-enhanced bacteriophage (crPhage™) precision medicine product targeting Escherichia coli (E. coli) bacteria causing urinary tract infections (UTIs).
These results demonstrate safety and tolerability for LBP-EC01 and help support the overall safety profile for Locus’ phage therapy platform. The trial met all of its primary and secondary endpoints and demonstrated proof of mechanism, as the world’s first completed, randomized, placebo-controlled trial of recombinant bacteriophage therapy.
The results indicate LBP-EC01 exposure can decrease the level of susceptible bacteria in patients infected with E. coli in the bladder. Through a unique dual mechanism, Locus Biosciences’ bacteriophage cocktail infects and replicates to burst target bacteria and the CRISPR-Cas3 technology improves the efficacy of the phages’ ability to kill, irreversibly destroying the bacterial genome without harming human cells or strains of beneficial bacteria. The study found no drug-related adverse effects, underscoring the safety of the company’s precision approach.
“We are thrilled to advance our company into Phase 2 human efficacy trials to prove CRISPR-Cas3 recombinant phage can precisely remove specific bacteria from the human body without harming any other bacteria in a patient’s microbiome,” said Paul Garofolo, Locus Biosciences CEO.
UTIs affect more than 12 million people a year in the US, with a third of those patients being burdened by recurrent UTIs (2 or more UTIs in the last 6 months or 3 or more UTIs in the last 12 months). The vast majority of these UTIs are caused by E. coli, including difficult-to-treat strains that are resistant to commonly used antibiotics. In fact, Locus has observed multi-drug resistance (MDR) rates (defined as resistant to 3 or more classes of antibiotics) in E. coli of approximately 28% and 30% respectively in its completed Phase 0 and Phase 1b trials. These levels of antimicrobial resistance (AMR) aligns with the alarming rate of increase projected by United Nations experts who warn that drug-resistant infections could cause 10 million deaths annually by 2050. The COVID-19 pandemic is further exacerbating the use of antibiotics worldwide, in turn fueling the growth of more drug-resistant bacteria.
With thousands of researchers around the world investigating links between bacteria and diseases ranging from cancer to Alzheimer’s, the company’s platform has the potential to prevent or cure many other diseases beyond drug-resistant bacterial infections.
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.
About the Phase 1b Trial
Study LBx-1001 was 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. 36 adult patients were enrolled. The study will had 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 neurology therapeutic areas. The Locus platform combines CRISPR-Cas3, which permanently degrades 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. For more information about Locus visit https://www.locus-bio.com/.
The Bulleit Group for Locus Biosciences