Pherecydes Pharma, a biotechnology company based in Romainville, France that specializes in the research and development of therapeutic lytic bacteriophages, announced the launch of the Phagoburn clinical trial, last month. This randomized 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. 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 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.
“Infections are the most common cause of mortality in burn patients,” said Dr. Patrick Jault, head of the anesthesia unit at the Percy Hospital and principal investigator for the trial. “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. This study is the result of a close collaboration between all of the stakeholders (SMEs, doctors, pharmacists, regulators, politicians etc.), with the goal of providing a common response to a public health issue.”
“The launch of this clinical trial is a big step for Pherecydes Pharma. Phagoburn has received all the necessary authorizations in France, Switzerland and Belgium; a testament to the quality of our phage therapy method and the development work put into the products tested,” said Jérôme Gabard, CEO of Pherecydes Pharma. “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.”
The WHO estimates that, in Europe and the United States, hospital-acquired infections (HAIs) affect 4 million and 1.7 million patients respectively. They are responsible for 147,000 and 99,000 direct and indirect fatalities each year. The annual costs incurred are estimated at €7 bn ($7.82bn) in Europe and $6.5bn (€5.82bn) in the United States. The rapid growth of antibiotic resistance means that this is a major public health issue.
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.