Phagoburn is the first clinical trial of its kind that will take place to evaluate the tolerance and effectiveness of two anti-infection bacteriophage treatments in serious burn patients
For the first time, an industry-standard clinical trial is evaluating the tolerance and effectiveness of phages in fighting sensitive antibiotic-resistant infections
Pherecydes Pharma, a biotechnology company, is launching the Phagoburn clinical trial to evaluate the tolerance and effectiveness of phages in fighting sensitive antibiotic-resistant infections.
Phage therapy is a therapeutic method for treating bacterial infections, in particular hospital-acquired infections and/or antibiotic-resistant infections.
The Phagoburn study by Pherecydes Pharma is the first international clinical study on phages in the world that meets international standards in clinical evaluation.
Phagoburn is a randomised and monitored phase I/II single-blind trial that aims to evaluate the tolerance and effectiveness of two anti-infection bacteriophage treatments in serious burn patients. (The effect of the bacteriophages is compared to a reference treatment: silver sulfadiazine.)
It will involve 220 patients for two products. One of the products targets bacterial infections caused by Escherichia coli, the other targets infections caused by Pseudomonas aeruginosa.
These species frequently and rapidly attain high levels of resistance to antibiotics which can be fatal if therapy fails.
Phagoburn is being conducted in 11 major burns units in France, Switzerland and Belgium. Two other military hospitals are also involved in the project and eight civilian hospitals.
Dr. Patrick Jault, principal investigator for the trial, said: “Infections are the most common cause of mortality in burn patients. Pherecydes’ approach, involving the use of phages, is an interesting one for us because it has the potential to open up a new avenue for therapy to counter antibiotic resistance through the use of a very rigorous procedure.”
Jérôme Gabard, CEO of Pherecydes Pharma, said: “Phage therapy is a promising solution to the problem of bacterial resistance. We see our therapy as both an alternative and a supplement to antibiotic treatment.”
Clean Cells, a French pharmaceutical company, carried out the bioproduction of the phages in line with current pharmaceutical good manufacturing practices (GMP).
CRO Statitec (France), which is responsible for managing the trial data and statistical aspects, is also participating in the project.