MHRA issues guidance on safe development of phage therapies
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (4 June) published the UK’s first official guidance to support the safe development and use of phage therapies – treatments that use viruses to target and destroy harmful bacteria.
The 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 covers both combined phage products designed for common infections and circulating strains, as well as personalised phage therapies that are tailored for individual patients with rare or highly resistant infections.
For patients, this could mean access to phage treatment when standard-of care-antibiotics fail or cannot be given, for example due to allergies.
While some patients in the UK have already received phage therapy under compassionate use – with phages imported from abroad – there are currently no licensed phage medicines on the UK market.
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.
“This guidance brings together relevant standards to provide clarity for researchers and companies, so they can develop these treatments safely and bring them to the people who need them.”
Phage therapies use bacterial viruses – called bacteriophages – that attack specific bacteria without harming human cells.
They have received increased interest in recent years as a potential way to treat antibiotic-resistant infections, with over 60,000 serious antibiotic-resistant infections estimated annually in the UK and growing.
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.
Frederique Vieville is BEAM Alliance Phage ACT Lead, a European group supporting antimicrobial therapy development, and 5QBD-Biotech Chief Executive, a biotech company focused on bacteriophage therapies.
Vieville said: “As difficult-to-treat infections continue to rise, phage therapy is becoming an important complement to existing treatments.
“Recent steps have been taken by European regulators to outline the regulatory framework for phage-based medicinal products, but developers still need support to navigate it effectively.
“Clarity about the pathway – tailored to the unique characteristics of phages – is vital to help meet quality, non-clinical, and clinical requirements, and ultimately bring phage-based treatments to patients more efficiently.”
Companies interested in developing bacteriophage treatments can access scientific advice from the MHRA at any stage of development.
