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

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

Details

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