In a significant boost to the fight against drug-resistant urinary tract infections (UTIs), Locus Biosciences Inc., a pioneer in biotechnology, has been granted a substantial $23.9 million funding by the Biomedical Advanced Research and Development Authority (BARDA). This infusion of capital is earmarked for the advancement of their groundbreaking CRISPR-engineered bacteriophage therapy, LBP-EC01, into the next phase of clinical trials.
Urinary tract infections, affecting an estimated 150 million people globally each year, are predominantly caused by the Escherichia coli (E. coli) bacteria. Alarmingly, around 80% of these infections are attributed to strains resistant to common antibiotics, presenting a significant challenge to healthcare systems worldwide. The Centers for Disease Control and Prevention and the World Health Organization have flagged antibiotic-resistant E. coli as a critical public health threat, underscoring the urgent need for innovative treatments.
LBP-EC01, Locus Biosciences’ flagship therapy, represents a breakthrough in this area. Utilizing CRISPR technology, it is specifically designed to combat UTIs caused by drug-resistant E. coli. The therapy has shown promising results in a Phase 2a clinical trial, paving the way for the release of funds from BARDA.
Paul Garofolo, Co-founder and CEO of Locus, expressed gratitude for the partnership with BARDA and emphasized the need for a large-scale, placebo-controlled study to conclusively demonstrate the efficacy of this novel therapy.
The ELIMINATE trial, a two-part, multicenter Phase 2 study, is at the heart of this development. The trial examines the use of LBP-EC01 in conjunction with the antibiotic trimethoprim/sulfamethoxazole in treating uncomplicated UTIs in adult females. The successful completion of Part 1 of this trial, which focused on safety, tolerability, and initial efficacy, has led to the release of this latest round of funding.
This funding is part of an $85 million contract with BARDA, contributing to a $152 million program supporting Phase 2 and Phase 3 trials and subsequent efforts for FDA approval. To date, $48.9 million has been released under this contract.
Locus Biosciences, headquartered in Research Triangle Park, N.C., is at the forefront of developing precision biotherapeutics. Their work in engineering bacteriophages to target pathogenic bacteria represents a significant leap in treating bacterial and microbiome/inflammatory diseases. With support from BARDA and other non-dilutive partnerships, Locus Biosciences continues to innovate in areas including infectious disease, immunology, and oncology.