Locus CEO Paul Garofolo.

Locus Biosciences Secures $23.9 Million to Advance Breakthrough UTI Treatment

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January 31, 2024

Locus Biosciences, a pioneering biotechnology firm specializing in precision-engineered bacteriophage therapies, has received $23.9 million in funding from the Biomedical Advanced Research and Development Authority (BARDA). This investment, part of an $85 million contract with BARDA, will propel the development of Locus' CRISPR-enhanced bacteriophage therapy, LBP-EC01, designed to combat drug-resistant Escherichia coli (E. coli) causing urinary tract infections (UTIs).

The funding follows the successful completion of the uncontrolled open-label Part 1 of the ELIMINATE Phase 2 trial, paving the way for Locus to advance into the blinded, placebo-controlled Part 2 phase. The ELIMINATE trial aims to evaluate the efficacy of LBP-EC01 in conjunction with trimethoprim/sulfamethoxazole (TMP/SMX) for treating UTIs caused by drug-resistant E. coli.

UTIs, affecting an estimated 150 million individuals annually worldwide, are predominantly caused by E. coli, with up to 40% of patients experiencing recurrence. The rise of antibiotic-resistant strains underscores the urgency for innovative treatments, as recognized by health authorities like the U.S. Centers for Disease Control and Prevention and the World Health Organization.

“Engineered bacteriophage have emerged as one of the most promising technologies for addressing the worldwide public health crisis of multi-drug resistant (MDR) bacterial infections. While multiple small-scale studies have shown promise, the field urgently needs a definitive large-scale placebo-controlled study to conclusively test the efficacy of an engineered bacteriophage therapy,” said Paul Garofolo, Co-founder and CEO of Locus. “We are incredibly grateful for our partnership with BARDA in funding this clinical trial of a potential first-in-class precision medicine for an important unmet medical need.”

LBP-EC01, a CRISPR-enhanced bacteriophage therapy, demonstrates a unique dual mechanism of action, harnessing both bacteriophage lytic activity and CRISPR-mediated DNA targeting. The therapy, previously validated in a Phase 1b trial, holds promise for treating UTIs and other infections caused by E. coli.

The ELIMINATE trial, a two-part Phase 2 study, will assess LBP-EC01's efficacy in adult female patients, furthering the quest for transformative treatments in UTI management.

This project receives federal support from the Department of Health and Human Services and underscores collaborative efforts to tackle antibiotic resistance. Patients interested in participating in the Phase 2 trial can find more information at www.eliminateuti.com.

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