The US Biomedical Advanced Research and Development Authority (BARDA) has allocated $24 million to support the advancement of a groundbreaking CRISPR-engineered bacteriophage therapy targeting antibiotic-resistant Escherichia coli infections. This funding, part of a broader $85 million award, will help Locus Biosciences progress its lead candidate LBP-EC01 through crucial mid-stage clinical trials.
The innovative therapy represents a novel approach to combating antimicrobial resistance by utilizing bacteriophages - viruses that specifically target and eliminate bacteria. LBP-EC01 distinguishes itself through its enhanced bacterial killing capability, achieved by combining natural bacteriophages with CRISPR/Cas3 gene-editing technology.
Clinical Development Progress
The ELIMINATE trial, currently in its phase 2 stage, focuses on female patients aged 18-65 with multi-drug resistant E. coli urinary tract infections and a history of recurrent UTIs. The BARDA funding will specifically support the advancement into the blinded, placebo-controlled portion of the study, with results expected in early 2024.
Paul Garofolo, co-founder and chief executive of Locus, emphasizes the significance of this development: "Engineered bacteriophage have emerged as one of the most promising technologies for addressing the worldwide public health crisis of MDR bacterial infections." He further notes the critical need for "a definitive large-scale placebo-controlled study to conclusively test the efficacy of an engineered bacteriophage therapy."
Addressing a Critical Healthcare Need
The development of LBP-EC01 addresses a significant global health challenge. UTIs affect approximately 150 million individuals annually, with E. coli responsible for 80% of cases. The recurrence rate is particularly concerning, with nearly 40% of patients experiencing subsequent infections within months of their initial episode.
Both the US Centers for Disease Control and Prevention and the World Health Organization have identified antibiotic-resistant E. coli as a serious public health threat requiring urgent attention and new treatment approaches.
Beyond E. coli: Expanding the Platform
Locus Biosciences' technology platform extends beyond E. coli infections. The company's pipeline includes phage-based therapeutics targeting other critical pathogens known for developing multi-drug resistance, including Pseudomonas aeruginosa, Staphylococcus aureus, and Klebsiella pneumoniae.
The selective nature of bacteriophage therapy offers a significant advantage over traditional antibiotics, as it can target specific pathogenic bacteria while preserving beneficial microorganisms in the body's microbiome. This precision approach could represent a paradigm shift in treating bacterial infections, particularly those resistant to conventional antibiotics.
