BARDA Funds Locus Biosciences $23.9M for Phase 2 CRISPR Bacteriophage Trial

Locus Biosciences, a clinical-stage biotech firm, is advancing its bacteriophage therapy, LBP-EC01, for urinary tract infections (UTIs) caused by drug-resistant E. coli. The company has received $23.9 million from BARDA, part of the U.S. Department of Health and Human Services, following positive Phase 2a trial results. UTIs impact approximately 150 million people globally annually, with E. coli accounting for around 80% of cases, often involving antibiotic-resistant strains. Both the CDC and WHO have flagged this as a critical public health issue.

Locus's engineered bacteriophages are seen as a promising solution to the multi-drug resistant bacterial infection crisis. The company has completed the open-label Part 1 of the ELIMINATE Phase 2 trial, which has led to the release of the BARDA funding. This will support the progression of LBP-EC01 into the blinded, placebo-controlled Part 2 of the trial.

The ELIMINATE trial is a two-part Phase 2 study that assesses LBP-EC01 in conjunction with trimethoprim/sulfamethoxazole for treating uncomplicated UTIs in adult females caused by drug-resistant E. coli. The open-label Part 1 evaluated the safety and efficacy of the therapy in 39 patients. Part 2 aims to determine LBP-EC01's efficacy compared to a control group, with a focus on clinical and microbiological responses in up to 288 patients.

LBP-EC01 is a bacteriophage cocktail enhanced with CRISPR-Cas3 technology, targeting the E. coli genome. It operates through a dual mechanism, combining the bacteriophage's natural lytic action with CRISPR's DNA-targeting capabilities. It has shown safety and tolerability in a Phase 1b trial and is currently under evaluation in a Phase 2 trial.

Locus Biosciences is developing a range of precision biotherapeutics using bacteriophages, which are viruses that specifically target and kill pathogenic bacteria. The company's platform is underpinned by bacteriophage discovery, synthetic biology, and manufacturing capabilities. Locus's AI and machine-learning engine identifies bacteria associated with diseases across various therapeutic areas, including infectious disease and oncology. The company has secured partnerships with BARDA and CARB-X to support the development of its platform and programs.