Promising Outcomes from Locus Biosciences' Phase 2 ELIMINATE Trial using Bacteriophage Therapy for Urinary Tract Infections
- Lindsey VanDyke
- Apr 30
- 2 min read
Locus Biosciences is advancing the ELIMINATE clinical trial, a pivotal study evaluating LBP-EC01, a CRISPR-enhanced bacteriophage therapy targeting multidrug-resistant (MDR) E. coli, the primary cause of urinary tract infections (UTIs). This two-part Phase 2/3 trial aims to assess the safety, efficacy, and potential of LBP-EC01 in treating UTIs, a condition affecting approximately 150 million individuals globally each year.locus-bio.com+1locus-bio.com+1
Part 1: Establishing Safety and Dosing Regimen
The first part of the trial was an open-label, dose-regimen selection study involving 39 adult female patients. Conducted across six U.S.-based clinical centers, this phase focused on determining the optimal dosing regimen of LBP-EC01 in combination with trimethoprim/sulfamethoxazole (TMP/SMX). The results were promising:
A dosing regimen of 2×10¹² plaque-forming units (PFU) per dose administered intra-urethrally for two days, alongside 1×10¹⁰ PFU per dose intravenously for three days, was well-tolerated.
All evaluable patients (16 of 16) experienced complete resolution of UTI symptoms.
87.5% (14 of 16) demonstrated microbiological cure or significant reduction in bacterial load.
No serious adverse events were reported, and no genetic resistance was observed in recovered E. coli samples.
These findings, published in The Lancet Infectious Diseases, provided the foundation for advancing to Part 2 of the trial.
Part 2: Evaluating Efficacy in a Controlled Setting
Building upon the success of Part 1, dosing has commenced in Part 2, a randomized, controlled, and blinded phase of the trial. This segment aims to rigorously assess the efficacy of LBP-EC01 in combination with TMP/SMX compared to a placebo control. The study plans to enroll up to 288 adult female patients across multiple sites in the U.S. and the EU. The primary endpoint is the combined clinical and microbiological response to acute uncomplicated UTIs caused by MDR E. coli.
A Collaborative Effort Against Antibiotic Resistance
The ELIMINATE trial is supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services. In 2024, BARDA released $23.9 million in funding to continue the development of LBP-EC01, underscoring the significance of this initiative in addressing the global health challenge posed by antibiotic-resistant infections.
Looking Ahead
As the ELIMINATE trial progresses, Locus Biosciences is at the forefront of developing precision bacteriophage therapies. LBP-EC01 represents a novel approach, utilizing CRISPR-Cas3 technology to target and eliminate E. coli infections while preserving beneficial microbiota. The outcomes of this trial could pave the way for new treatment paradigms in the fight against antibiotic-resistant infections.
For more information on the ELIMINATE trial or to learn about participation opportunities, visit www.eliminateuti.com.
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