REPhRAME partners at the centre of major bacteriophage therapy developments
Interest in phage therapy is growing in the EU among the scientific and clinical communities, as well as policymakers. Discovered in the early 20th century, phage therapy predates antibiotics but has seen renewed interest in recent years as antibiotic resistance continues to grow and threatens the efficacy of many current standard treatments. Bacteriophages, or phages, are viruses that selectively infect and kill bacteria, including strains resistant to antibiotics.
Many REPhRAME partners are active participants in these renewed efforts to safely integrate phage therapy into clinical practice in Europe and have helped shape recent milestones in the field.
New guideline for safe and standardised use of personalised phage therapy
A new consensus-based guideline was published in Nature Medicine in September, providing practical recommendations for the safe and standardised use of personalised bacteriophage therapy. The publication marks an important step towards establishing the clinical and regulatory frameworks needed to translate phage therapy into medical practice. Four members of the REPhRAME consortium - Silvia Würstle, Simone C. Lieberknecht-Jouy, Shawna McCallin and Lorenz Leitner - are among the guideline’s authors.
Despite a growing number of individual treatment attempts and case series, evidence from large, controlled clinical trials remains limited. At the same time, common standards are needed for aspects such as selecting suitable phages, preparing them at the required quality, administering treatment, and monitoring patients.
The new consensus guideline aims to address these gaps. The guideline provides more than 60 recommendations and statements covering the general principles of personalised phage therapy, infrastructure, phage preparation and quality control, clinical administration, monitoring and documentation, as well as priorities for future research.
Recommendations include systematically documenting phage treatments in national or international registries. Collecting harmonised information on treatments, outcomes and unexpected events could help generate the evidence needed to further develop phage therapy and inform future clinical studies.
EU-level cooperation and funding needed to progress the field
For phage therapy to be integrated into routine clinical practice, understanding its potential to address antimicrobial resistance must extend beyond the scientific community and individual clinicians, hospitals, or even countries. A recent Panel for the Future of Science and Technology (STOA) workshop at the European Parliament aimed to explore the potential of phage therapy as a strategy to address antimicrobial resistance, and asked speakers to dedicate particular attention to the regulatory, clinical, and practical hurdles still standing in its way.
The session was moderated by Annika Classen (University Hospital Cologne) and featured REPhRAME partners Kārlis Rācenis (Rīga Stradiņš University) and Silvia Würstle (University Medicine Frankfurt) as speakers. They spoke about their clinical work and research on phage therapy, and the hurdles they currently encounter when treating patients. They also highlighted the need for stronger EU-wide collaboration and the creation of joint tools, such as a large phage bank and a common registry of phage therapy cases.
The new guideline was emphasised as an important development in the field, along with the need for future funding of adaptive trials for personalised phage therapy.
The EU has already recognised the need to advance this field, as reflected in last year’s Horizon Europe call for proposals, through which REPhRAME and two other initiatives received funding for clinical trials of phage-based therapies.
The approach investigated in REPhRAME differs from the personalised phage therapy addressed by the new guideline and discussed at the workshop: rather than selecting and preparing phages individually for each patient, REPhRAME evaluates a defined CRISPR-armed phage cocktail targeting specific strains of Escherichia coli. Nevertheless, both personalised phage therapy and defined phage-based products form part of the broader effort to establish phage-based treatments on a robust scientific, clinical and regulatory foundation.
REPhRAME contributes to this effort by generating clinical evidence for a new treatment strategy for recurrent urinary tract infections (rUTIs), a condition that continues to rely heavily on antibiotics and is increasingly affected by antimicrobial resistance. At the heart of the project is a multicentre randomised clinical trial evaluating a bacteriophage-based investigational medicinal product to treat acute infection, alongside an approach to restore the intestinal microbiome and help prevent recurrence.
The involvement of REPhRAME researchers in these recent developments reflects the breadth of phage expertise within the consortium and connects the project to broader international efforts to establish standards, generate reliable clinical evidence, and define how phage-based therapies can be safely integrated into clinical practice.
