2 Accepted

Further clinical trials required to prove consistent effectiveness of phages and combinations

Conclusion
Clinical data indicates that in many cases phages have been observed to reduce bacterial infections in patients. We also heard that their use in animals has also been shown to be effective. However, further clinical trials are required to prove the consistent effectiveness of phages. Such studies need to include analysis of the impact of different phage cocktails as well as phage/antibiotic combinations.
Government Response Summary
The government described existing provisions for researchers, including access to bacterial strain panels and expertise, and highlighted funding opportunities through NIHR and UKRI. It specifically noted Innovate UK's recently launched £30 million PACE initiative to accelerate early-stage innovation in AMR, including phage projects.
Paragraph Reference
40
Government Response
Accepted
HM Government Accepted
1. Access for researchers to bacterial strain panels, biofilm, and infection models for evaluation of the efficacy of phage and phage-cocktails against clinically relevant bacterial strains. Delivered through an Open Innovation AMR programme and previously supported by an NIHR infrastructure grant (NIHR200658), this enables researchers to work directly with UKHSA to evaluate new approaches and generate data to support grants and funding applications 2. Expertise and novel approaches for the rapid susceptibility profiling of clinical isolates against phage or phage cocktails, to support the development of phage cocktails, the provision of data to clinicians looking to use phage in clinical settings and, in the longer term, aiming to support patient recruitment into clinical trials 3. Studies exploring the synergy and antagonism of phage when used with 'standard of care' antibiotics and looking at the changes in antimicrobial susceptibility and virulence linked to emergence of phage-resistance in WHO priority pathogens 4. Working with others to develop new concepts of use and target product profiles (TPPs) for phage, to support their evaluation and implementation in the clinic 5. Working with others to understand the appropriate regulatory frameworks for the manufacture of phage for clinical use, aligned with the concepts of use for different patient groups. Evaluation of novel methods for GMP that could support future clinical implementation of phage In addition to these current activities, UKHSA will consider appropriate activity to develop further research partnerships in this area alongside the NIHR Health Protection Research Units (HPRUs). NIHR offers funding through 'researcher-led' programmes. The researcher-led workstream invites applications in response to calls for research on specific questions, which have been identified and prioritised for their importance to the NHS and patients. Proposals may include primary research, evidence synthesis, or feasibility and pilot studies. UKRI (across its different councils) also offers substantial funding opportunities for phage research. For example, Innovate UK has recently launched PACE 'Pathways to antimicrobial clinical efficacy' (4) – a £30 million initiative with LifeArc and Medicines Discovery Catapult to accelerate early-stage innovation in AMR, with phage projects within its scope. The VMD engages with the UK KTN Phage Innovation Network and researchers working on phage based VMP, when approached, providing support to these stakeholders on a product specific basis.
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age 2.4 yrs
Report published 03 Jan 2024