Uncomplicated UTI CRISPR-Cas3 Treatment Shows Positive Results

As millions of women and men continue battling the impact of urinary tract infections (UTI), innovative, advanced technology therapies are progressing through clinical trials.

A recent Phase 2 trial evaluating LBP-EC01, a CRISPR-Cas3 genetically engineered bacteriophage therapy designed to treat patients with uncomplicated urinary tract infections (uUTIs) caused by antimicrobial-resistant (AMR) and multi-drug-resistant (MDR) Escherichia coli (E. coli), reported positive news.

CRISPR–Cas technologies have enabled programmable gene editing.

This study's primary and secondary objectives were met in the open-label randomized Part 1 of the clinical trial to treat uUTIs caused by antibiotic-resistant E. coli.

Locus Biosciences's CFO Joseph Nixon previously stated, 'Like all of our products, LBP-EC01 is very selective for the target pathogen, preserving the many species of beneficial bacteria in the patient's microbiome.' 

On August 12, 2024, Locus Biosciences, which is developing a new class of precision-engineered bacteriophage treatments for a diverse set of bacterial diseases, announced the first public report of data from the randomized, uncontrolled, open-label Part 1 of its two-part, U.S. government-funded Phase 2 ELIMINATE trial.

Published by The Lancet Infectious Diseases, 39 UTI patients were randomly assigned between August 2022 and August 2023. After the protocol was updated, 31 participants were allocated into three groups with different dosing regimens.

"A regimen consisting of two days of intraurethral LBP-EC01 and three days of concurrent intravenous LBP-EC01 (1 × 1×1010 PFU) and oral TMP–SMX twice a day was well tolerated, with consistent pharmacokinetic profiles in urine and blood."

LBP-EC01 and TMP–SMX dosing resulted in a rapid and durable reduction of E. coli, eliminating clinical symptoms in evaluable patients.

These researchers concluded that 'LBP-EC01 holds promise in providing an alternative therapy for uUTIs, with further testing of the group A dosing regimen planned in the controlled, double-blind, second part of ELIMINATE.'

Juvenal E. Martinez, M.D., an investigator in the trial, said in a press release, "As the first Phase 2 engineered bacteriophage trial, ELIMINATE is breaking new ground in the quest to address increasingly prevalent serious MDR infections."

"This encouraging initial data supports the possible utility of bacteriophages and the potential of LBP-EC01 as a therapeutic option to address drug-resistant bacterial infections, such as UTIs, which have a high recurrence rate due to MDR pathogens."

This clinical trial is supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.

In January 2024, BARDA provided the company with $23.9 million in research funding. BARDA previously committed up to $93 million to Locus for a $152 million program to support Phase 2 and Phase 3 clinical trials and other activities required to seek marketing approval from the U.S. FDA for LBP-EC01.

Additional UTI therapies and vaccine development information is posted by Precision Vaccinations.