Clinical trials for phage therapy in urinary tract infections have begun

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

This multicenter clinical trial is the first in which phage preparations from the PhageBank™ library are administered intravenously (IV) or via bladder instillation.

PhageBank™ is a constantly expanding bacteriophage library operated by Mayo Clinic Laboratories. The library is an integrated logistics platform that selects specific phages for a particular pathogenic bacterium and provides them for therapy as needed.

Previously, PhageBank™ phage medications were successfully used as “investigational drugs” in 40 patients. UTI is the first of several indications in which clinical trials will test the potential of PhageBank™ in treating infections that do not respond well to antibiotic therapy. The next indications for which trials are scheduled to begin in 2022 are prosthetic joint infections and diabetic foot osteomyelitis.

The current study is being conducted at several US medical centers with 156 patients and is an interventional, randomized, placebo-controlled, open-label trial. Participants include those with urinary tract infections 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 phage preparations prior to use in patients with symptomatic infections and a high risk of relapse. Patients will be monitored for bacterial infections and the recurrence of urinary tract diseases.

The study organizers hope that the Phase I/II results will form the basis for conducting a pivotal Phase II/III trial on the use of phage medications in patients with chronic and recurrent urinary tract infections.