A Study of LBP-EC01 in the Treatment of Acute Uncomplicated Urinary Tract Infection Caused by Multi-drug Resistant Escherichia Coli (E. Coli)

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a Phase 2/3 superiority study of LBP-EC01, a recombinant bacteriophage cocktail, with an initial 3-arm pharmacokinetic (PK) lead-in portion of 30 patients to evaluate the optimal dosing regimen to be used in the subsequent 550 patient portion of the study which will be randomized 1:1 comparing LBP-EC01 + antibiotic versus placebo + antibiotic in patients with a history of prior urinary tract infection (UTI) cased by E. coli. All patients will be required to have an active acute uncomplicated UTI at baseline.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Locus Biosciences
• Collaborator: Parexel
• Treatments: Calcium; Calcium Carbonate

Criteria

Inclusion Criteria:

• History of recurrent UTI defined as ≥2 UTIs in the past 6 months or ≥ 3 UTIs in the past 12 months prior to Screening (Day 1/Visit 1) with at least one of these caused by E. coli (as single pathogen or part of polymicrobial infection where E. coli was the predominant pathogen at quantitation ≥ 1.0 × 10^5 colony forming units [CFU]/mL) based on culture results/documentation.

• History of positive urine culture with presence of MDR OR extended spectrum beta-lactamases (ESBL) E. coli within the last 12 months.

• Able to supply a mid-stream, clean catch urine sample for microbiological analysis.

• Active acute uUTI infection defined by:

a. Evidence of pyuria: i. >10 white blood cell (WBC)/mL3 on microscopic evaluation of spun, clean, mid-stream urine specimen or >3 WBC/high power field on unspun clean, mid-stream urine specimen, AND/OR ii. Dipstick analysis of a clean, mid-stream urine specimen positive for leukocytes, AND/OR iii. Positive catalase test of a clean, mid-stream urine specimen. AND b. At least 2 of the following signs or symptoms of UTI: dysuria, urinary frequency, urinary urgency, or suprapubic pain"

• Willing to comply with all aspects of study design including study restrictions, blood, urine, and stool sampling, and scheduled study visits.

• All sexually active female patients of childbearing potential must use highly effective contraception during the study and until 2 weeks after the last dose of study drug treatment.

• Agrees to STOP the use of cranberry products, probiotics (Lactobacillus spp), D-mannose, OM-89 (various strains of E. coli), continuous low dose antimicrobial prophylaxis and/or post-coital antimicrobial prophylaxis to prevent UTI for the entire study duration (throughout the 6-month follow-up period or study discharge).

• Agrees to not use any prescription or non-prescription medication for the microbiological or symptomatic treatment of the presenting acute uUTI for the first 10 days of the study.

• Capable of providing their own signed informed consent form (ICF) prior to any study-related procedures being performed.

• If participating in Part 1 of the study, agrees to fast for ≥2 h prior to first dose of study drug on Day 1/Visit 1 except for drinking 240 mL of water with study drug administration.

Exclusion Criteria:

• Pregnant or nursing women.

• Allergies to excipients of the study drug or antibiotics.

• History of autonomic dysreflexia.

• History of intravenous (IV) drug abuse or is currently using or has positive results for drugs of abuse at screening.

• Signs or symptoms of systemic illness such as fever greater than 38° Centigrade/Celsius, shaking chills, or other clinical manifestations suggestive of complicated UTI.

• Treatment with other antibacterial drugs including those that are effective for treatment of the acute uUTI or prevention of recurrent UTI in the 3 days prior to Screening unless the recovered pathogen demonstrates resistance to the initial antibiotic and clinical symptoms persist.

• Clinical symptoms for more than 7 days before Screening.

• Presence of indwelling urinary bladder catheters, urinary tract anatomical abnormalities, poorly-controlled diabetes mellitus, immunocompromising condition and/or treatment, or advanced renal disfunction.

• Clinically significant serious unstable physical illness that in the investigator's opinion prevents patient from completing the study or prevents interpretation or resolution of clinical symptoms.

• Exposure to any investigational drugs or other phage therapy 30 days prior to Screening (D1/V1) or prior to participation in this study. Patients who participate in Part 1 are not eligible for participation in Part 2.

• Patients who reside in a long-term care facility.

• Suspected or confirmed acute coronavirus disease 2019 (COVID-19) or recent COVID-19 infection with ongoing symptoms.