Phase I/II clinical trials have begun in the United States to evaluate the efficacy and safety of personalized phage preparations in patients with urinary tract infections (UTIs) caused by multidrug-resistant bacteria. The trials were initiated by Adaptive Phage Therapeutics (USA) using its own continually expanding phage library, PhageBank™.

This multi-center clinical trial is the first to use PhageBank™ library phage products intravenously (IV) or as bladder instillations.

PhageBank™ is a continuously expanding bacteriophage library hosted by Mayo Clinic Laboratories. The library is an integrated logistics platform that, on demand, selects and delivers phages specific to a specific bacterial pathogen for therapy.

PhageBank™ phage preparations have previously been successfully used in 40 patients as "experimental therapies." UTI is the first of several indications for which clinical trials will test the potential of PhageBank™ for the treatment of infections that are poorly responsive to antibiotics. The next indications, for which trials are expected to begin in 2022, are joint prosthetic infections and diabetic foot osteomyelitis.

The current trial, which is being conducted at multiple US medical centers and involves 156 patients, is an interventional, randomized, placebo-controlled, open-label trial. Participants are treated with UTIs caused by E. coli or K. pneumoniae . Results from the first cohort will be used to confirm or modify the dosing regimen and route of administration of the phage preparation before use in patients with symptomatic infections and a high risk of recurrence. Patients will be monitored for bacterial infection and urinary tract disease recurrence.

The study's organizers hope that the results of Phase I/II will form the basis for conducting pivotal Phase II/III studies on the use of phage preparations in patients with chronic and recurrent UTIs.