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Trial Underway Testing Crispr-Based Antibiotic

E. coli

Escherichia coli, or E. coli, bacteria (National Institute of Allergy and Infectious Diseases)

8 Jan. 2020. A clinical trial is recruiting participants to test an antibiotic made with engineered viruses, in people threatened with urinary tract infections from E. coli bacteria. The study is sponsored by Locus Biosciences, a biotechnology company in Morrisville, North Carolina developing the antibiotic.

Escherichia coli, or E. coli, bacteria are responsible for 80 to 90 percent of urinary tract infections, which occur most often among women, in the bladder and urethra. If left untreated, these infections can spread to the kidneys or beyond with serious consequences. National Kidney Foundation says urinary tract infections are responsible for some 10 million doctor visits a year in the U.S., with at least 1 in 5 women likely to have an infection in her lifetime.

Locus Biosciences develops antibiotics starting with viruses called bacteriophages, natural enemies of bacteria. Bacteriophages infect and replicate inside bacteria, during which time the viruses produce lysin enzymes. Lysins then break down the walls of bacterial cells, destroying the bacteria. Locus Biosciences uses high-speed discovery methods to identify bacteriophages, or phages, with features needed to combat certain bacteria, then designs a specific cocktail of phages for each target.

The company’s technology, however, goes one step further, adding a form of Crispr to the phages. Crispr — short for clustered, regularly interspaced short palindromic repeats — is known as a technique for editing the genomes of organisms by harnessing bacterial defense mechanisms that use RNA to identify and monitor precise locations in DNA. For gene editing, Crispr uses enzymes like Cas9 that cut DNA at precise locations. For antibiotics, Locus Biosciences replaces Cas9 with the enzyme Cas3, which the company says shreds DNA beyond repair, killing bacterial cells.

The clinical trial is testing the company’s lead product, code-named LBP-EC01, a phage cocktail boosted with Crispr-Cas3 and designed to attack and kill E. coli bacteria. The early-stage trial is enrolling 30 adults using urinary catheters, with a history of urinary tract infections or found having current E. coli colonies. Only one site for the study is identified so far, in Laguna Hills, California, but other sites are expected.

Participants are randomly assigned to receive LBP-EC01 or a placebo, with twice as many LBP-EC01 as placebo recipients. The study is looking primarily for signs of adverse effects from LBP-EC01, indicating safety or tolerability issues, but are also testing blood and urine samples as indicators of the treatment’s chemical activity in the body.

Locus Biosciences says the clinical trial is the first study in humans of engineered bacteriophages as antibiotics. “It represents an important milestone for the company,” says Locus Biosciences chief development officer Paul Kim in a company statement, “and for the field of bacteriophage therapy.”

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