Pherecydes Pharma launches multi-centre clinical study of phage therapy in serious burn victims

The industry-standard clinical trial is evaluating the tolerance and effectiveness of phages in fighting sensitive antibiotic-resistant infections

Pherecydes Pharma, a biotech company specialised in the research and development of therapeutic lytic bacteriophages, announced the launch of the Phagoburn clinical trial. This randomised and monitored phase I/II single-blind trial 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.

Phage therapy is an innovative therapeutic method for treating bacterial infections, in particular hospital-acquired infections and/or antibiotic-resistant infections. Reportedly, this is the first international clinical study on phages in the world that meets international standards in clinical evaluation. It will involve 220 patients spread across two arms: 110 patients for each of the two bacteriophages cocktails developed by Pherecydes Pharma. One of the products targets bacterial infections caused by Escherichia coli, the other targets infections caused by Pseudomonas aeruginosa. Infections involving these germs are often very severe. These species frequently and rapidly attain high levels of resistance to antibiotics. This can be fatal if therapy fails. The trial began in July 2015.

Phagoburn is coordinated by the Percy Military Hospital (France), a Service de Santé des Armées (SSA) Hospital within the French Ministry of Defence. It is being conducted in 11 major burns units in France, Switzerland and Belgium. Two other military hospitals are involved in the project – the Reine Astrid Hospital in Brussels (Belgium) and the Sainte-Anne Military Hospital in Toulon (France). Eight civilian hospitals are also taking part: the Liège teaching hospital (CHU) and the Grand-Hôpital of Charleroi-Loverval (Belgium), the Vaud CHU (Switzerland), the St Joseph/St Luc Hospital in Lyon, the Nantes and Bordeaux CHUs, the Metz-Thionville regional hospital and the Conception hospital in Marseille (France).

Clean Cells, a French pharma company, carried out the bioproduction of the phages in line with current pharma good manufacturing practices (GMP). CRO Statitec (France), which is responsible for managing the trial data and statistical aspects, is also participating in the project.

Phagoburn is part of a European FP7 project. The study, launched in June 2013 for a period of three years, has received €3.85 million ($4.3 million) in European Union funding.