Locus Biosciences (Locus) has begun treating the first patient in its phase 2/3 trial of LBP-EC01, in partnership with the Biomedical Advanced Research and Development Authority (BARDA), for the treatment of urinary tract infections (UTIs) caused by Escherichia coli (E coli) bacteria, the clinical-stage biotechnology company announced.
An estimated 150 million people are affected by UITs each year, with approximately 80% of these cases caused by E coli. This often includes difficult-to-treat strains that are resistant to commonly used antibiotics.
Antibiotic-resistant E coli has been identified by both the US Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) as an ‘urgent and serious’ public health threat requiring development of new treatments.
The ELIMINATE trial of LBP-EC01 – a CRISPR-enhanced bacteriophage (crPhage) precision medicine – in combination with a commonly used antibiotic will enrol approximately 800 female patients between 18-65 years of age who have UTIs caused by multi-drug resistant (MDR) E coli and have a history of prior UTIs caused by E coli.
The study follows positive results from a phase 1b clinical trial of LBP-EC01, which met all primary and secondary endpoints and demonstrated safety and tolerability for LBP-EC01.
Paul Garofolo, co-founder and chief executive officer of Locus, said: “This trial represents a significant milestone for Locus’ CRISPR-Cas3-enhanced bacteriophage, as we work to realise the potential of our precision medicines for bacterial-related diseases, and for the field as this is the first statistically powered registration-enabling trial for a bacteriophage therapy.
“Locus and our partner, BARDA, believe LBP-EC01 may offer a potentially first-in-class treatment to address the emerging worldwide public health crisis of MDR bacteria and we hope to be able to confirm and build upon the positive results seen in our prior phase 1b trial in this phase 2/3 trial.”
In 2020, Locus and BARDA – part of the Administration for Strategic Preparedness and Response (ASPR) at the US Department of Health and Human Services – announced an agreement to co-fund development of LBP-EC01.
Under the terms of the agreement, BARDA will provide up to $77m funding to Locus as part of a $144m programme to support phase 2/3 clinical trials and other activities required to seek marketing approval from the US Food and Drug Administration (FDA) for LBP-EC01.