Can phage therapy help us in the fight against antibiotic resistance?

By Emer Cooke – Executive Director of the European Medicines Agency

Bacteria resistant to antibiotics pose a major threat to our health, but certain viruses pose a major threat to resistant bacteria. These viruses are known as bacteriophages, or phages for short. Their name comes from Greek and it means “to devour” – because this is exactly what such viruses do: thriving while eating bacteria.

More than a century ago, the taste of phages for bacteria caught the attention of scientists in the pharmaceutical field. Successful treatments of bacterial infections took place a decade before penicillin was discovered. But once antibiotics became what we thought to be the silver bullet against different types of infections, this interest faded in Western countries. Antibiotics were easier to make, store, and prescribe.

Fast-forward to today, and the implications of antibiotic-resistant bacteria have pushed researchers to rediscover an interest in bacteriophages. Antimicrobial resistance is estimated to cause the death of more than 35.000 Europeans every year and puts a significant burden on our healthcare systems. It is also estimated that AMR-related deaths worldwide could reach 10 million people a year by 2050 if we do nothing to preserve our current effective antibiotics, develop new ones or find alternatives.

But how does phage therapy work? Phages don’t infect and cause disease in people. They selectively target and kill bacteria in humans

While phages can be found everywhere, from soil to seawater, from plants to our own bodies, finding the right phage and matching it successfully with a specific bacteria causing an infection takes time and resources.

This is only one challenge of using phage therapy as a viable alternative to antibiotics. Other challenges are the lack of clinical trials to test the effectiveness of phage therapy as well as the complexity of manufacturing processes and control strategies to ensure consistent quality of bacteriophage active substances and finished products.

Now is the right time to encourage scientific discussion around phage therapy.

We see already some concrete steps: the U.S. Food and Drug Administration (FDA) is using phage therapy as part of its compassionate use programme, while the Australian Therapeutic Goods Administration (TGA) makes it available to patients who have qualified to receive treatment under a special access scheme. European countries like Belgium, France and Sweden run established phage therapy programs in addition to long-standing programs in Georgia and Poland.

We at EMA published a guideline on quality, safety and efficacy of veterinary medicines specifically designed for phage therapy. We have also launched a public consultation on a draft concept paper on the development and manufacturing of phage medicinal products intended for the treatment or prevention of bacterial infections in people. I encourage interested companies, but also healthcare professionals, academics and patients to share their views and questions with us, which will feed into a scientific guideline to be released for a second round of consultations. Our goal is to pave the way towards more rigorous research and evidence generation, so that ultimately we pave the way for new therapies to be submitted for a marketing authorisation in the EU.

We need to explore the potential of any new therapy that can effectively address antibiotic resistance, while finding smart solutions to overcome the challenges. I want to take this opportunity to encourage pharmaceutical companies working with bacteriophages to come to us early and to discuss their development plans.