In October 2018, The Lancet published the final report* of the international PhagoBurn project, which aimed to evaluate the clinical potential of bacteriophages in the treatment of burn wounds infected with Escherichia coli and Pseudomonas aeruginosa (Phase I-II clinical trials). The project was supported by the European Commission's Framework Programme 7 and began in 2013.

PhagoBurn is the world's first prospective, multi-center, randomized, single-blind, controlled clinical trial of phage therapy, conducted in accordance with GMP and GCP (Good Manufacturing Practices and Clinical Practices) standards.

The study was conducted from July 2015 to January 2017. Twenty-seven patients with burn wounds infected with E. coli and P. aeruginosa were divided into two groups: one received standard treatment, the other received phage therapy. E. coli and P. aeruginosa are infections that are common in burn units and difficult to treat due to multidrug resistance. The use of low concentrations of phage preparations was shown to reduce bacterial contamination of wounds, albeit more slowly than standard treatment. The next phase of research requires testing the effectiveness of higher doses of bacteriophages in a larger number of participants.

The following results of the PhagoBurn project are of great importance for the future development of phage therapy:

Significant progress has been made in the regulatory aspects of phage therapy. At the start of the project, no EU country other than Poland was using bacteriophages. Patients with antibiotic-resistant infections were forced to travel to Tbilisi, Georgia, to the Eliava Institute of Bacteriophages to have their individual phage cocktails prepared. The PhagoBurn project sparked discussions on the potential use of bacteriophages in clinical practice, and a process was developed for the French regulator, ANSM, to issue temporary authorizations for use (ATUs) for phage preparations. Such authorizations were also issued for the phage cocktails used in the clinical trial.

- the production of phage cocktails in accordance with GMP standards was developed;

The most important result of the research is proof of the high safety of phage therapy. The obtained data on phage safety are precisely what regulatory authorities involved in drug registration want to know first.

Due to regulatory and manufacturing issues during the project, only 13 months remained for the actual clinical trials. As a result, fewer participants were recruited than planned. This was also due to the fact that burn wounds are typically infected with many different types of bacteria, and the study required recruiting patients with Escherichia coli and Pseudomonas aeruginosa infections. Despite these and other challenges, the clinical trial was informative and motivating for further work.

The PhagoBurn project has shown that bacteriophages (phage therapy) are a promising alternative to antibiotics.

* Jault P, Leclerc T, Jennes S et al. Efficacy and tolerance of a cocktail of bacteriophages to treat burn wounds infected by Pseudomonas aeruginosa (PhagoBurn): a randomized, controlled, double-blind phase 1/2 trial // The Lancet, Published: October 03, 2018. DOI:https://doi.org/10.1016/S1473-3099(18)30482-1