The growing resistance of bacteria to antibiotics threatens, according to the World Health Organisation, sending modern medicine back decades to an era “when even routine surgeries were hazardous”.
But a recent inquiry by the Science, Innovation and Technology Committee, which I chair, has heard compelling evidence of a medical treatment that can evade anti-microbial resistance.
Bacteriophages, or phages for short, are viruses that invade specific bacteria and destroy them. They have shown success in treating deadly infections that are resistant to antibiotics. But, even after years of research and growing evidence of their efficacy, phages have never been licensed for therapeutic use in the UK. They have only been used here as “compassionate” treatments of last resort in a small number of cases, using phages imported from overseas.
Medical interest in phages increased in 2019, after the recovery in Britain of a teenager with an untreatable lung infection. After a nine-month stay at Great Ormond Street hospital she returned to her home in Kent for palliative care but recovered after her consultant teamed up with a US laboratory to develop a specific phage therapy. Afterwards, the lab received requests from doctors around the world seeking hope for their patients.
Phages are not a panacea. They are specific to an individual infection and may require months of laboratory development. The UK is developing a ‘library’ of phages, with advanced genomic sequencing and understanding of the viruses’ therapeutic interactions. But to begin to realise the benefits of phage treatment at scale, we need clinical trials. And that is where the UK is at an impasse.
Current UK regulations require the phages used for clinical trials to be manufactured to an exacting set of standards known as Good Manufacturing Practices or GMP. Here there is a Catch-22 problem. We cannot conduct clinical trials until we can manufacture phages to GMP standards, but we cannot manufacture phages to GMP standards without significant investment in qualifying design, equipment, installation and processes which will not be forthcoming without successful clinical trials.
Our Select Committee’s report recommends establishing a small collective manufacturing facility in which researchers and companies can produce phages to GMP standards without incurring the full set up costs of a manufacturing facility themselves. This has precedents in the Catapult network, which provides collective test facilities for advanced manufacturing companies and for new satellites being developed.
One such facility, which has already received over £1 billion of public funding, could be the Rosalind Franklin Laboratory in the West Midlands. This state-of-the-art testing and diagnostic lab was established by the Government to bring an end the inadequacy of testing capacity that so hampered the national response to Covid. It consists of modern, secure laboratory facilities and was meant to be an important source of national resilience against future pandemics. But the Rosalind Franklin Laboratory has suddenly appeared for sale on the property website Rightmove, to the astonishment of the science and health communities. Our Committee’s report on phages asks for the Rosalind Franklin Laboratory to be considered for this purpose, rather than be lost to the nation and to science in a firesale.
In the meantime, we recommend that the UK medicines regulator, the Medicines and Healthcare Products Regulatory Agency, should consider allowing the compassionate, last resort use of non-GMP phages produced in the UK.
Phages are an example of personalised medicine, in which therapeutic medicines are bespoke to the patient. How we approach the licensing of bacteriophages may supply useful lessons and experience as our respected medical regulators, world-renowned researchers and innovative life sciences sector work together on treatments that may offer solutions to the some of the world’s biggest problems, like antimicrobial resistance.
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