The antimicrobial potential of bacteriophages – Report Summary

Summary

Antimicrobial resistance (AMR) poses a serious global threat to our ability to treat bacterial infections. New antibiotics have often proved difficult and expensive to develop. This has led to an interest being rekindled in an older form of antimicrobials—bacteriophages (phages)—viruses that ‘eat’ bacteria. They can treat bacterial infections and reduce resistance to antibiotics by removing barriers—biofilms—which have evolved and reduced antimicrobial effectiveness. Each phage can target individual bacteria, can be combined with multiple phages and antibiotics, and adapted specifically for each individual patient. Phages have been described as a ‘personalised medicine’—a group of treatments adapted to each patient.

The further development of phage therapies face significant challenges that will need to be overcome if their potential is to be fully realised. Like many personalised medicines, they currently struggle to meet regulations designed for conventional medicines produced to a single formulation. In the UK phages have not been manufactured to required Good Manufacturing Process (GMP) standards, precluding UK-produced phages from clinical use. The small quantities of phages that have been used in the UK are imported, usually not to GMP standards, and are heavily restricted because they are unlicensed.

Regulators should address these issues at pace. The Medicines and Healthcare Products Regulatory Agency (MHRA) should consider using a ‘magistral monograph’, as is the case in Belgium, to allow non-GMP phages to be produced in the UK to an acceptable standard for compassionate cases. Regulators should set out what standards will be required for phages to meet clinical trial and GMP standards, reflecting their unique characteristics and specificity for each patient treated. This work should be used to inform regulation of personalised medicine more generally.

This impasse of phages being unlicensed, and therefore their minimal deployment in the UK, has hindered attempts to integrate phages within our health system. With the lack of a route to a return on investment, there has not been significant investment in phage infrastructure. This has stalled a roll out of phage biobanks, a systematic network of phage laboratories to produce specific phage formulations or the manufacturing capability to produce more generic phages for humans and for use in other areas, such as animals and aquaculture.

The Department for Health and Social Care (DHSC) should consider bringing together funders with relevant catapults and innovation centres to build a GMP facility that can be accessed and used by phage innovators, the NHS and those seeking to produce other personalised medicines, such as microbiome products. The DHSC should also set out how it will help develop a network for sharing phage-related knowledge, and assets such as biobanks.

Despite the UK hosting some leading phage researchers and research centres, and acknowledgement of the role they could play, key funders have appeared reticent to back phage research. Whilst research indicates that phages are comparatively safe, further work can address remaining concerns, and develop a body of evidence to demonstrate both their safety and effectiveness. Such research could harness the UK’s genomic research prowess and artificial intelligence to quickly match phages to bacteria and allow manipulation to increase effectiveness. The National Institute for Health and Care Research and the UK Health Security Agency should engage with phage researchers to improve prospects for phage related applications for research funding.

More broadly, the Government should produce a clear statement on the role that phages could play in fighting AMR and how they will be supported.