The UK’s phage therapy gap – and how to close it

In January, I visited the House of Lords to give evidence on behalf of CPI to the Science and Technology Committee on the antimicrobial potential of bacteriophages. 

Phage therapy — the use of bacteriophages to treat bacterial infections — holds real promise for solving the growing crisis of antimicrobial resistance (AMR). However, despite increasing research interest in the UK, barriers to phage development put us at risk of being left behind as international colleagues forge ahead towards this new frontier. 

The goal of the session was to hear directly from experts on why and how phage could transform the health landscape, and how the UK can be a part of this expanding field. So, what did we share, and learn?

What is holding the UK back?

Right now, we simply don’t have the infrastructure to get phage therapies into clinical trials. Current UK capabilities, like those at CPI, have so far been limited to pre-clinical studies.

We lack Good Manufacturing Practice (GMP)-compliant phage production facilities, and this means that companies and researchers must look beyond the UK to take the next steps towards commercialisation after pre-clinical work. This is particularly onerous for small and medium-sized enterprises (SMEs). It’s also a missed economic opportunity for the UK.

And even where we’re working on phage therapies at the earlier stage, we’re hindered by the lack of a specialised workforce to develop and scale these innovations. There are few professionals in the UK that have direct experience in phage therapy; nor do we have a clear pipeline of students with the knowledge base and technical expertise to fill the gap.

Those innovators who are managing to break into the phage space, are coming up against the challenge of a regulatory system not quite suited to these new therapies. For example, phage therapies often rely on ​‘phage cocktails’: mixtures of multiple bacteriophages designed to target a broad range of bacteria. These phage cocktails need periodic updates to remain effective: as bacterial strains evolve, so, too, must these cocktails. Allowing these updates to happen without repeating validation processes, like clinical trials, would ensure greater efficiency in phage production.

We already have a similar approach to the flu vaccine, which changes each year. However, clarity on how this could work with phages would be one way to make development easier for companies, helping get therapies to market — and patients — faster.

Underpinning all of these challenges is a lack of funding. Increasing investment in people, facilities, and regulation updates would enable us to unlock the potential of this exciting innovation.

It’s not all doom and gloom

It’s important to acknowledge the positive changes we have seen in this field over the last few years. The Phage Innovation Network, for example, launched in November 2022, has worked to coordinate efforts and foster collaboration across academia, industry, and healthcare.

Meanwhile, the PACE programme, a collaboration between Innovate UK, LifeArc, and the Medicines Discovery Catapult, is driving the development of new solutions for AMR. The programme funds projects like PhalconBio, which is developing a phage therapy to tackle pulmonary infections.

The MHRA has taken some steps in providing regulatory advice. It has developed guidance for phage therapies with support from CPI and other industry and academic partners, which will be published soon.

At CPI, we already support the development, optimisation and scale-up of manufacturing processes for phages with our end-to-end production, purification and characterisation capabilities.

We have also collaborated with companies and institutions on phage research. These initiatives include our work with Liverpool University, where our Researchers in Residence (RiR) project is focused on bridging academia and industry to advance process development, manufacturing, and analysis that will help get therapeutic phage candidates into the clinic. We will also be working with the university on a Microbiome and Infectious Disease (MaID) Innovation Hub that will drive the development and commercialisation of microbiome therapies and novel antimicrobials including phages.

But there is still a lot of work to do.

Where do we go from here?

Firstly, the UK must invest in boosting manufacturing capabilities to support GMP-compliant phage production. It’s simple: if we can’t create the products to a quality necessary to test them, we will not be able to support British research centres and companies, big or small, to take their product from idea to clinic. Companies developing new phage products will have to go outside of the UK to get GMP phage manufactured, representing a lost opportunity for the UK from both a healthcare and economic perspective.

To solve our skills gap and workforce challenges, we should create a microbiome and phage bioprocess innovation centre. It would act as a translational hub within the UK’s current ecosystem, bringing together expertise, and providing end-to-end support for SMEs, start-ups, and entrepreneurs. It could also double up as a core space for training a new generation of phage experts.

When it comes to updating our regulations, the development of reference standards would help researchers who are developing phage therapies. Phages have some unique features compared with other biopharmaceuticals, making a well-characterised reference standard essential. At CPI, we are already collaborating with the MHRA and Prof. Martha Clokie at the University of Leicester in developing and analysing standards to support manufacturing and characterisation.

Overall, a national strategy for the development and use of phages would help us achieve these goals. A clear outline, developed and supported by academia, industry, and regulatory bodies, that sets out end-to-end pathways for the design, development, manufacture, and delivery of phage therapies within the UK and internationally, would help align all those invested in phage development and focus our skills and utilities on clear goals.

Building today will pay dividends tomorrow

The AMR crisis has created an urgent demand for an alternative to antibiotic treatments, but we won’t get phage therapies to those who need them most without the facilities, the people, and the networks that foster and guide research innovation.

Phage therapies will be transformative for global health. We must act now to put the UK at the heart of this exciting time in medicines research.