Antibiotic-resistant infections are a particular concern with large-scale use of antibiotics to treat secondary infections during a pandemic, such as those caused by H1N1 influenza or SARS-CoV-2, and in treating infections caused by biothreat agents, such as anthrax or tularemia, that require 60 days or more of antibiotic therapy.
Locus Biosciences today announced the release of $23.9 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to continue the development of Locus’ CRISPR-enhanced bacteriophage therapy, LBP-EC01, for treating urinary tract infections (UTIs) caused by drug-resistant Escherichia coli (E. coli).
The company’s recent successful completion of the uncontrolled open-label Part 1 portion of the two-part ELIMINATE Phase 2 trial triggered the release of this tranche of funding under its $85 million contract (75A50120C00169) with BARDA. The funding will be used to advance LBP-EC01 into the blinded, placebo-controlled, Part 2 of the ELIMINATE Phase 2 trial.
Worldwide, an estimated 150 million people are affected by UTIs each year. Approximately 80% of these are caused by E. coli, often including difficult-to-treat strains that are resistant to commonly used antibiotics. Up to 40% of UTI patients experience a recurrence, often within months of the first episode. Both the U.S. Centers for Disease Control and Prevention and the World Health Organization have identified antibiotic-resistant E. coli as an urgent and serious public health threat requiring development of new treatments.
“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. 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.”
Paul Garofolo, Co-founder and CEO of Locus
In 2020, Locus and BARDA announced an agreement to co-fund development of LBP-EC01. Under the contract, BARDA will provide up to $85 million in funding to Locus as part of a $152 million program to support Phase 2 and Phase 3 clinical trials and other activities required to seek marketing approval from the U.S. Food and Drug Administration for LBP-EC01. The award announced today brings the amount released under the contract to $48.9 million.
About the ELIMINATE Trial
The two-part multicenter Phase 2 ELIMINATE trial is evaluating LBP-EC01 used concomitantly with trimethoprim/sulfamethoxazole (TMP/SMX) in adult female patients for the treatment of uncomplicated UTIs caused by drug resistant E. coli. The uncontrolled open-label Part 1 (dose-regimen selection) evaluated the safety, tolerability, pharmacokinetics and clinical and microbiologic outcomes of LBP-EC01 and TMP/SMX in 39 patients with uncomplicated UTI. Part 2 of the study has a primary objective of determining the efficacy of LBP-EC01 when used concomitantly with TMP/SMX, compared to control (placebo plus TMP/SMX), based on combined clinical and microbiological response of acute uUTI caused by drug resistant E. coli in up to 288 adult female patients.
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract number 75A50120C00169. For more information, visit clinicaltrials.gov using the identifier NCT05488340.
Patients interested in participating in Part 2 of the Phase 2 trial can visit www.eliminateuti.com.
About LBP-EC01
LBP-EC01 is a CRISPR-enhanced bacteriophage therapy in development for the treatment of urinary tract infections and other infections caused by the bacterial pathogen Escherichia coli (E. coli). It is a bacteriophage cocktail engineered with a CRISPR-Cas3 construct targeting the E. coli genome. The precision medicine product works through a unique dual mechanism of action utilizing both the natural lytic activity of the bacteriophage along with the DNA-targeting activity of CRISPR. LBP-EC01 previously met all primary and secondary endpoints and demonstrated safety and tolerability in a Phase 1b trial. LBP-EC01 is currently being evaluated in a Phase 2 trial for the treatment of UTIs caused by E. coli.