A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

Inclusion Criteria:

• History of UTI in the past 12 months and prior or current uUTI caused by AMR E. coli (as single pathogen or part of polymicrobial infection where E. coli is thepredominant pathogen). Please note that the current infection can be used to meetthe requirement of AMR E. coli documentation.

• 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 evaluationof spun, clean, mid-stream urine specimen or >3 WBC/high power field on unspunclean, mid-stream urine specimen, AND/OR ii. Dipstick analysis of a clean,mid-stream urine specimen positive for leukocytes, AND b. At least 2 of thefollowing signs or symptoms of UTI: dysuria, urinary frequency, urinary urgency, orsuprapubic 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 highlyeffective contraception during the study and until 2 weeks after the last dose ofstudy drug treatment.

• Agrees to STOP continuous low dose antimicrobial prophylaxis and/or will maintainthe same practices for post-coital antimicrobial prophylaxis to prevent UTI, asduring the prior 12-months, for the entire study duration (throughout the 6-monthfollow-up period or study discharge).

• Agrees to not use any prescription or non-prescription medication for themicrobiological 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 anystudy-related procedures being performed.

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

Exclusion Criteria:

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

• Treatment with other antibacterial drugs including those that are effective fortreatment of the acute uUTI or prevention of recurrent UTI in the 5 days prior toScreening unless the recovered pathogen demonstrates resistance to the initialantibiotic and clinical symptoms persist. In postmenopausal women vaginal estrogenreplacement therapy is permitted so long as patient meets all other eligibilitycriteria, that the dose and regimen has be stable for > 3 months from Screening (D1/V1), and that there is no planned change to therapy through the 6-monthfollow-up period or study discontinuation.

• Clinical symptoms for more than 5 days before Screening.

• Presence of indwelling urinary bladder catheters, urinary tract anatomicalabnormalities that increase UTI risk or lead to a post void residual (PVR) urinevolume > 150mL, poorly controlled diabetes mellitus (diagnosed but is not beingtreated/managed by a physician's care or HbA1c >8), current symptomatic or largerthan 5mm renal calculi, or advanced renal dysfunction (determined by eGFR < 45mL/min/1.73 m2). Patients with vaginal prolapse beyond the hymen with Valsalva (e.g., when coughing).

• Individuals considered to be immunocompromised.

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

• Pregnant or nursing women.

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

• 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 resultsfor drugs of abuse at screening.

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

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