The UK’s first official guidance to support the ‘safe development and use’ of phage therapies has been published by the Medicines and Healthcare products Regulatory Agency (MHRA).
Phage therapies use bacterial viruses – called bacteriophages – to target and destroy harmful bacteria without harming human cells.
While there are currently no licensed phage medicines on the UK market, the MHRA said there had been ‘increased interest’ in phage therapies as a potential way to treat antibiotic-resistant infections.
The new MHRA guidance aims to help researchers and companies develop phage-based medicines that meet UK safety, quality and efficacy standards, ‘so they can be made available to patients who need them most’, it said.
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And the regulator said its publication ‘could mean access to phage treatment when standard-of care-antibiotics fail or cannot be given, for example due to allergies’.
The 28-page document sets out how existing UK and international regulatory frameworks apply to phage treatments – from early research through to use in patients.
Combined phage products designed for common infections and circulated strains are covered within the guidance, as well as the use of personalised phage therapies that are tailored for individual patients with rare or highly resistant infections.
Some patients in the UK have already received phage therapy under compassionate use, with phages imported from abroad, the regulator noted.
Lawrence Tallon, MHRA chief executive, said: ‘Some infections are becoming harder to treat when antibiotics are ineffective against them – and patients urgently need new options.
‘Phage therapy is one of several promising approaches.’
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He added: ‘We’re committed to working with industry to support innovation in this space – without compromising on the robust safety and quality standards that patients rightly expect.
‘It’s part of our wider mission to support innovation and make the UK a world leader in life sciences.’
The publication supports the government’s 2024-2029 National Action Plan to tackle antimicrobial resistance (AMR) – which in May 2024 pledged to support pharmacist prescribers with tools to reduce unnecessary antimicrobial prescriptions as part of its five-year plan.
Dr Colin Brown, deputy director at the UK Health Security Agency (UKHSA), responsible for AMR, said phage therapy ‘truly has the potential to transform the way we treat bacterial infections, especially as resistance to antibiotics grows’.
He explained how the UKHSA was currently ‘developing new ways to help increase phage therapy use and research, including a bacteriophage collection where scientists can both access and deposit phages’.
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‘In time, we hope solutions like phage therapy can become a first-line treatment option,’ he added.
The MHRA developed the guidance with input from the Phage Innovation Network, a cross-sector group supported by Innovate UK, and from industry, clinicians and academic researchers.
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