ELIMINATE trial is evaluating LBP-EC01 for treating urinary tract infections caused by drug-resistant E. coli
Funding to support advancement into Part 2 of ELIMINATE trial
Research Triangle Park, N.C., January 23, 2024 – Locus Biosciences, Inc. (“Locus”), a clinical-stage biotechnology company developing a new class of precision engineered bacteriophage treatments for a diverse set of bacterial diseases, 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) based on positive results from a Phase 2a clinical 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,” 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.”
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.
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.
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.
About Locus Biosciences
Locus Biosciences is creating a new class of precision biotherapeutics with clinical-stage engineered bacteriophage treatments for a diverse set of bacterial and microbiome/inflammatory diseases. A world-leading bacteriophage discovery, synthetic biology, and manufacturing platform powers the company. Locus engineers bacteriophage – naturally occurring viruses that target bacteria – to kill pathogenic bacteria, while sparing good bacteria, through programmable precision anti-bacterials with CRISPR-Cas3 and other therapeutic payloads. Its artificial intelligence and machine-learning based discovery engine targets bacteria that are associated with disease across therapeutic areas including infectious disease, immunology, and oncology. Locus has secured multiple non-dilutive partnerships to support development of the company’s platform and programs. These include contracts with Biomedical Advanced Research and Development Authority (BARDA) for Locus’ lead asset targeting E. coli and Combatting Antibiotic Resistant Bacteria Accelerator (CARB-X) for Locus’ asset targeting K. pneumoniae. For more on the Research Triangle Park, N.C.-based company, visit www.locus-bio.com.