A trial supported by National Institute of Health’s National Institute of Allergy and Infectious Diseases to investigate the safety and efficacy of an experimental phage therapy “WRAIR-PAM-CF1” against chronic Pseudomonas aeruginosa infection in the airways of adults with cystic fibrosis (CF) has started in the United States. The phase 1b multicenter trial conducted by the  Antibacterial Resistance Leadership Group (ARLG) will recruit up to 72 patients with cystic fibrosis from across the country.

According to an NIH press release, the components of WRAIR-PAM-CF1 include “a cocktail of four bacteriophage species that naturally infect P. aeruginosa and take over its cellular processes, killing the bacterium in the process. The phages in the cocktail are highly specific and do not attack human cells”. The press release further states that these phages do not carry harmful genes such as those pertaining to antibiotic resistance, which could inadvertently be transferred to the bacteria they infect.

Three doses of the anti-pseudomonal phage therapy would be tested. One of the three doses would be administered to each participant as a single IV infusion. To begin with, in stage1 of the trial, the three doses would be tested on two participants for each dose followed by close monitoring of the volunteers for four days. A preliminary analysis will be carried out to determine the dose. Up to 50 participants would be enrolled for stage 2 of the trial if there are no significant severe safety concerns in stage 1. The study subjects would then be randomized to receive either the selected dose of the experimental therapy or a placebo. They would be regularly screened on follow-up visits.

Will phage therapy circumvent the escalating crisis of antibiotic resistance? Only time will tell.

Source: NIH Press Release, October 4, 2022. Available at: https://www.nih.gov/news-events/news-releases/nih-supported-clinical-trial-phage-therapy-cystic-fibrosis-begins.