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Scientists react to the 2023-2024 SIT committee report on the antimicrobial potential of bacteriophages.
Dr Ken Bruce, Senior Lecturer in Molecular Microbiology at King’s College London, said:
“Overall, this is a very positive development. The renewed interest in the use of phage therapy represents a positive step in terms of dealing with clinical infection. Phage therapies have been used for many years and interest in the UK is now growing within the scientific community.
“Phages have been shown in many studies to be effective in resolving infections, and the conclusions in the report have been backed up by solid data from what I can see. This development could go further for instance including omic strategies and the consequences on the impact of the microbiome.”
Prof Chloe James, Microbiology Society member, and Chair in Microbiology, University of Salford, said:
“This report marks an important and very welcome step change in the advancement of phage therapy. I was very pleased to see the launch of this inquiry, and the gathering of evidence from a wide network of trusted phage experts from across the UK and beyond. I believe that phages represent a range of promising ways to tackle antimicrobial resistant infections. However, the approach has long faced multiple barriers and I am pleased to see that these are acknowledged. The report recognises that such barriers could be overcome with new ways of thinking both on how to classify medicines and how to run clinical trials. The need for improved understanding amongst clinicians about the nature of phages is also mentioned. I think that this will be very important more broadly to build lasting public trust. The suggestion of establishing an Institute for novel microbe-based therapeutics could be a great to boost UK research. An injection of funding is also needed to create a sustainable and accessible asset that could transform our approaches to healthcare.”
Prof Catherine Rees, Professor of Microbiology, and Deputy Head of Division of Microbiology, Brewing & Biotechnology, University of Nottingham, said:
“The potential of bacteriophage (viruses that only kill bacteria) to treat bacterial infections was recognised soon after their discover over 100 years ago. However, antibiotics proved to be easier to develop and manufacture, so there were not developed into commercial treatments. Now the increasing threat of antibiotic resistant bacteria means that there is a growing need to find different ways to treat infections – and phage could just provide the answer.
“Advances in genetics means that phage, including their strengths and weaknesses, are now better understood. The report recognises that the UK has a strong community of researchers ready to help develop phage therapy, including writing the necessary regulatory framework required to allow phage products to be made more widely available while ensuring public safety. It is encouraging that this report also addresses the practical issues, such as the need to support the R&D work required to turn scientific knowledge into commercial phage products and the need to support the specialist facilities required to make these products to the required safety standards. Its recommendations are both practical and wide ranging that, if implemented, could pave the way for the UK to become world leaders in the development of phage-based products.”
Prof Martha Clokie, Professor of Microbiology, and Director of the Centre for Phage Research, University of Leicester, said:
“The Press Release accurately captures the essence of the report which is an accurate summary of where Phage research is at within the UK and how it should be taken forward. Whereas the Press Release focusses on phage production and on the currently limitations of the UK not having capacity to produce phages at the necessary level of purity needed to treat patients, the actual report itself is broader and centres on the fact that the UK is facing a real crisis with increasing numbers of patients dying from bacterial infections that can’t be treated. The Select committee have independently and systematically carried out an Inquiry of all the evidence surrounding the safety and efficacy of using phages as medicines as well as assessing all the funding and structural challenges that surround the development of new medicines. They concluded that the UK should invest more in this research area to save lives. Structural changes are also recommended in terms of the regulators and policy makers working more closely with researchers and clinical practitioners, along with the provision of infrastructure such as Phage Banks and GMP facilities. Ultimately this should result in the saving of a significant number of lives, reduce misery and suffering from chronic infections and save the NHS considerable resource. The committee acknowledged all social and scientific hurdles that need to be overcome to make this happen but are fully supportive that this would be money well spent.”
Dr Francis Hassard, Senior Lecturer in Public Health Microbiology, School of Water, Energy and Environment, Cranfield University, said:
“The report (Antimicrobial Potential of Bacteriophages) highlights an intriguing yet nascent area in medical science. While it underscores the promise of phages in combating antibiotic-resistant infections, the field is still in its infancy, lacking significant randomized controlled trials of sufficient scale and repeatability (i.e., most trials are currently Phase I and II). The optimism associated with phage therapy should be tempered with a call for more rigorous translational scientific research to affirm both efficacy and safety of phage therapy. As we face the growing challenge of antimicrobial resistance, phage therapy presents a potential, albeit not yet fully realized, avenue for innovative treatments using principles derived from precision medicine.
Does the press release accurately reflect the report / the science?
“The report provides a comprehensive overview of bacteriophage therapy, aligning well with the scientific understanding of phages as potential antimicrobial agents. The press release accurately captures this complexity and the current research status.
Is this report based on good quality research? Are the conclusions backed up by solid data?
“The report is grounded in substantial research, discussing various aspects of phage therapy, including historical context, mechanisms, and potential applications. It references existing studies, data and consults various suitable experts, indicating a solid research foundation.
How does this work fit with the existing evidence?
“The document aligns with the broader scientific discourse on combating antimicrobial resistance (AMR). It fits into existing evidence by acknowledging both the significant potential and the challenges of phage therapy.
Have the authors accounted for confounders? Are there important limitations to be aware of?
“The report recognizes significant confounders and limitations, such as the specificity of phages, lack of standardised and approved doses, the substantial regulatory barriers, and the need for more targeted research.
What are the implications in the real world? Is there any overspeculation?
“It outlines real-world implications, particularly in healthcare and food safety, while maintaining a quite balanced view. The report avoids excessive speculation, instead focusing on the current state of research and practical challenges. However, the report could be considered slightly optimistic and speculative in terms of benefits phage therapy could convey, practically. One aspect the report did not consider is the regulatory framework developed during vaccine testing for COVID-19 and whether this could be adapted for Phage therapy. Specifically: The UK utilized a rapid and “rolling review” process, allowing the Medicines and Healthcare products Regulatory Agency (MHRA) to evaluate vaccine data as it became available, speeding up the review process. The MHRA collaborated with international regulatory bodies (European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), sharing data and insights to expedite the vaccine review process. COVID-19 vaccines were granted temporary emergency use authorization by the MHRA, based on strong evidence of safety and efficacy, enabling quicker public access. Vaccine approval decisions were informed by independent scientific advice and review from expert bodies like the Commission on Human Medicines. Post-authorization, there was robust surveillance of the vaccines’ safety and efficacy in real-world use, ensuring continuous assessment and addressing any safety concerns. Could a similar approach be adopted for phage therapy?”
Dr Willames Martins, Postdoctoral Researcher, Ineos Oxford Institute for Antimicrobial Research, said:
Does the press release accurately reflect the report / the science?
“The press release is a short summary of the report highlighting important factors for the awareness of phage use in the UK. The bullet points in the press release reinforce substantial topics discussed through the report and are important to guide the readers about what the Science, Innovation and Technology Committee wants to address.
Is this report based on good quality research? Are the conclusions backed up by solid data?
“The report has good scientific quality as the research is based on real experience and scientific evidence of experts dealing with hard-to-treat infections, especially those caused by drug-resistant pathogens. It is important to note that different points of view were addressed in the construction of this report: i) bacteriophages experts; ii) regulatory agencies; iii) clinicians; and iv) British research founders. Thoughts from authorities in these different areas provide an opportunity to look at the potential of bacteriophages in a unique way, understanding their importance at this time, whilst recognising their limitations and the steps required for their implementation in clinical practice.
How does this work fit with the existing evidence?
“This report highlights that bacteriophages are an important weapon in our arsenal to combat the rise of antimicrobial resistance (AMR). It is evident that phage therapy requires more attention from both a regulatory and a funding perspective, to ensure promising research is translated into positive clinical outcomes for patients. It is a crucial step for the UK government to recognise phages as an alternative therapy to combat drug-resistant infections, and this recognition paves the way for a commitment of additional funding for this valuable research.
Have the authors accounted for confounders? Are there important limitations to be aware of?
“No that I am aware of.
What are the implications in the real world? Is there any overspeculation?
“This is the first step of many to improve AMR management using bacteriophages as an emergent tool. Although phages can be used used clinically, their use extends far beyond that. Further research is needed to unravel how phages interact in the human body, in particular their interactions with the immune system.
“This report identifies both the potential and the current limitations of phage therapy. Further research and evidence-based guidelines are urgently needed to maximise the potential of bacteriophages in the face of the growing burden of antimicrobial resistance.”
Prof Debbie Shawcross, Professor of Hepatology and Chronic Liver Failure, King’s College London, said
“The report demonstrates the obstacles in gaining support for developmental treatments, especially in a time of increasing anti-microbial resistance. The failure for clinicians to obtain funding for studies involving phages, acknowledged in the report as a ‘translational phage research gap’ has been driven by a lack of an established regulatory framework and the requirement by the MHRA for the manufacture of a GMP-licensed phage product to undertake such a trial.
“This is not however insurmountable, and clinicians have paved the way by building GMP-manufacture facilities that have enabled treatments such as faecal transplants (which contain trillions of bacteriophages) obtained from healthy donors to be tested in UK clinical trials to treat liver disease, antimicrobial resistance and arthritis. The final perceived barrier outlined in the report is whether patients would be willing and confident to receive ‘viruses’, especially those that have been genetically modified in a post-COVID-19 era that whilst are unlikely to do any harm, have not yet had their safety tested in clinical trials.
“This very important and timely report should serve as an urgent call to action for UK Research Council Funders and the Medicines Health Regulatory Agency to support Clinician Scientists to establish GMP-funded phage manufacture facilities within a regulatory framework to enable ‘first in man’ clinical trials to be undertaken to assess their safety and efficacy in a variety of clinical settings.”
Dr Kourosh Ebrahimi, Lecturer in Immunology & Drug Discovery at King’s College London, said:
“Bacteriophages are specific viruses that target and kill bacteria, with each phage able to target a particular bacterium. As a result, bacteriophages are emerging at the frontiers of developing new personalised bio-based therapeutics to overcome the threat posed by the rising number of bacterial species resistant to antibiotics.
“To realise the full therapeutic potential of phages, further collaboration is required to discover and generate a biobank of natural and engineered phages, provide robust clinical data regarding the safety and efficacy of using phages to treat different bacterial infections, and understand how phages interact with a body’s immune response.”
Dr Simon Clarke, Associate Professor in Cellular Microbiology, and Head of Division of Biomedical Sciences & Biomedical Engineering, University of Reading, said:
“Phage have long been regarded as a possible avenue for development of new antimicrobials, they were extensively researched in the former Soviet Union, but they are not without shortcomings. They can stimulate a patient’s immune system, potentially tipping them into shock or they could simply be quickly removed by the liver rendering them of little use; bacteria develop resistance to them easily, meaning that new, expensive treatments might become useless pretty quickly; and they are one of the ways nature uses to move around genes which cause a bacteria to become resistant to traditional antibiotics, so the widespread use of phage could lead to even more antibiotic resistant infections. Perhaps most worryingly they can also transfer genes which give bacteria different disease-causing properties, potentially leading to the development of novel, virulent pathogens.
“In addition to prolonging the use of the drugs we already have, through stewarding their appropriate use, there are other, more promising approaches to tacking antimicrobial resistance. For example, while development of new antibiotics is slow, combining drugs that we already have has shown some effectiveness and there has been progress in developing drugs that block resistance when it’s encountered. We need to combine strategies like these with more traditional hunts for new antibiotics and vaccine development, to turn the tide on antimicrobial resistance.”
Dr Andrew Singer, Principal Environmental Microbiologist, UK Centre for Ecology & Hydrology (UKCEH), said:
“The House of Commons Science, Innovation and Technology Committee’s report entitled “The antimicrobial potential of bacteriophages” is a truly exciting effort to remove the roadblocks that stand in the way of the use of bacteriophages for combatting bacterial infections in the UK. The hurdles identified in the report are relatively surmountable from the perspective of the science of using bacteriophage in a clinical setting. The real challenge appears to be in their regulation as a ‘medicine’. The role of this report appears to be a catalyst to inspire the government to remove these barriers. The removal of such barriers will lead to the UK having ‘homegrown’ bacteriophage production, which is likely to translate into a significant increase in bacteriophage research, transforming the UK into a global leader in this area of medicine while offering potentially globally relevant solutions to the silent pandemic of antimicrobial resistant infections.”
Dr Anthony Lockett, Senior Lecturer in the Centre for Pharmaceutical Medicine Research, King’s College London, said:
“We know that more people will be seeking antibiotics for colds and flu this time of year. Anti-microbial resistance is on the rise, and the pressures on public health should be a warning call to government officials of the need to focus on the development of bacteriophages.
“The report summarises the situation well and is realistic in expectations; it highlights the issues of personalised medicine in general, and antimicrobial therapy in particular. With many infections now multi-resistant, it is clear this is a time to catch up on phage research. However, as the report points out, the economics of an antibacterial approach are costly and the hurdles and barriers are high, just as they were to the COVID vaccine technologies. When pushing for the development of new technology innovation like phages, experts need to consider the facilitation of costs and regulation.”
Dr Lindsey Edwards, Lecturer in Microbiology, King’s College London, said:
“Often called ‘the silent coming plague’, antimicrobial resistance is a huge global health challenge, and drug-resistant infections are once again a leading cause of death worldwide. This jeopardises our ability to treat patients safely, burdens healthcare systems and complexifies care delivery for the most vulnerable in society. Reliable alternatives must be found.
“Phages have been used as therapy for over a hundred years, and much of the fundamental science relating to phages is understood. However, as this timely report points out, there is still more that the global and UK research communities can learn, and further research will be crucial to be able to establish key issues such as long-term interactions between phages and human hosts.
“More infrastructure and investment are needed to advance the research and clinical trials to support the manufacture of these phages in GMP-compliant facilities in a safe manner, all of which the UK is in a strong position to do.”
‘House of Commons Science, Innovation and Technology Committee: The antimicrobial potential of bacteriophages; First Report of Session 2023–24’ was published at 00:01 UK time on Wednesday 3 January 2024.
Declared interests
Dr Ken Bruce: “No conflicts of interest.”
Prof Chloe James: “I am a phage researcher and active in public engagement to enhance public understanding of phage biology. My research does not involve the development of phage therapy.”
Prof Catherine Rees: “I have no interests to declare in the area of phage therapy, but I am a co-founder and share holder in PBD Biotech Ltd, which produces a phage-based diagnostic product. I also gave evidence to this scientific enquiry.”
Prof Martha Clokie: “No personal financial interests.
I am the Director of the Centre for Phage Research which is under the umbrella of the Department of Genetics and Genome Biology at the University of Leicester. The Centre receives funding from UKRI, charities and commercial companies to carry out phage research. The report supports further research income to the Centre (and to all phage and associated stakeholders) to carry out the fundamental work needed to tackle current and future global challenges with a focus on bacterial infections. On behalf of the Centre for Phage research I supplied written and spoken evidence to the Inquiry.”
Dr Francis Hassard: “No known conflicts of interest to declare. We have had a project on bacteriophages funded by the UK water sector through the UK Water Industry Research. But this was on drinking water quality so quite un-related to the report.”
Dr Willames Martins: “No conflicts.”
Prof Debbie Shawcross: “No competing interests.”
Dr Kourosh Ebrahimi: “No competing interests.”
Dr Simon Clarke: “I have no conflicts.”
Dr Andrew Singer: “I have no conflicts of interest.”
Dr Anthony Lockett: “No competing interests.”
Dr Lindsey Edwards: “No competing interests.”