Developing Phages into Medicines for Europe

Abstract

With the recognition of the threat posed by bacterial multi-drug resistance, the bacteriophage treatment concept has been revived as an alternative in the armamentarium. Over the last decade, research efforts on bacteriophage therapy have intensified, and stakeholders have called upon regulatory authorities in trying to define a bespoke licensing pathway for bacteriophages which would not adversely affect the standards required for quality, safety and efficacy. In this context, and in particular concerning the use of personalised phage cocktails, the concept of “hybrid licensing”, with patient-specific phage therapy selected from a local pre-authorised phage library, has recently been advanced. To date, however, and notwithstanding encouraging data, important knowledge gaps remain regarding the safe and effective administration of bacteriophages. Therefore, generation of further scientifically robust data concerning proposed bacteriophage therapies as well as extensive stakeholder consultation, including engagement with relevant competent authorities, would be important in facilitating bacteriophage therapeutic development and its successful introduction into the clinic.