The Medicines and Healthcare products Regulatory Agency (MHRA) has published the U.K.’s first official guidance to support the safe development and use of phage therapies. The guidance aims to help researchers and companies develop phage-based medicines that meet U.K. 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 personalized 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 U.K. have already received phage therapy under compassionate use—with phages imported from abroad—there are currently no licensed phage medicines on the U.K. market.
“Some infections are becoming harder to treat when antibiotics are ineffective against them, and patients urgently need new options,” says Lawrence Tallon, chief executive of MHRA. “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.
“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.”
Phage therapies use bacterial viruses (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 U.K. and growing.
Clear and practical advice
The MHRA’s publication sets out how existing U.K. and international regulatory frameworks apply to phage treatments from early research through to use in patients. It was published to provide clear, practical advice on what’s needed at each stage of development, whether the goal is a fully licensed product or a treatment used under a clinician’s responsibility for an individual case.
Further detail in the guidance includes what evidence is needed to support clinical trials and market authorization; how to meet standards on quality, safety and manufacturing, including the application of Good Manufacturing Practice (GMP); how personalized treatments can be developed and supplied; and when and how unlicensed phage treatments can be used for individual patients.
The 28-page document brings together U.K. and international regulatory standards in one place, helping innovators clearly understand what’s required and avoid unnecessary delays.
“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,” notes Frederique Vieville, BEAM Alliance Phage ACT Lead (a European group supporting antimicrobial therapy development) and chief executive of 5QBD. 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.”
“There is an urgent and increasing need for new ways to treat antimicrobial resistant infections, with bacteriophage being at the forefront of recent developments,” stresses Jason Clark, PhD, director and CSO at NexaBiome. “This new guidance from the MHRA is incredibly forward-thinking and puts the U.K. in pole position to fully realize the healthcare and commercial benefits of this exiting technology.
“As a company developing bacteriophage products for human use, this guidance helps us to decrease perceived risks and gives clarity to the regulatory landscape, ultimately enabling us to more readily bring investment into the U.K.”
Companies interested in developing bacteriophage treatments can access scientific advice from the MHRA at any stage of development.
For more information, access Regulatory considerations for therapeutic use of bacteriophages in the U.K. on the MHRA website.
