Australia is experiencing a rising threat from AMR, where bacteria and other microorganisms can survive in the presence of drugs intended to eliminate them, such as antibiotics, largely due to over-exposure, commonly because of misuse or overuse.
AMR undermines the effectiveness of medicines and makes infections more difficult to treat.
A review published today in npj Antimicrobials and Resistance presents an Australian perspective on the potential of nano-antimicrobial (NAM) therapies to mitigate the impact of antimicrobial resistance (AMR) and highlights the scientific, regulatory, and manufacturing challenges that must be overcome to implement their use.
NAM therapies are part of the expanding field of nanomedicine, which utilises nanoparticles to prevent, diagnose, treat, and monitor diseases. Operating at the nanoscale (one nanometre equals one billionth of a metre), nanomedicine holds promise for treating diseases that are currently challenging or impossible to treat.
These therapies offer a promising approach to combating AMR by employing mechanisms not available to conventional antimicrobials. These mechanisms include targeted delivery of lower antimicrobial doses, disruption of drug-resistant biofilms, and direct inhibition of microbial growth.
Dr Jen Payne, co-lead author and researcher at CSIRO’s Manufacturing Research Unit, says that while NAM therapies, used in conjunction with existing antimicrobials, offer the potential to improve patient outcomes and combat rising antimicrobial resistance, they face similar market access and commercialisation challenges as other AMR solutions. These challenges, combined with manufacturing and regulatory obstacles, must be considered early in the design process to facilitate a smoother path to market.
"Nano-antimicrobial therapies represent a promising niche opportunity," Dr Payne said.
"But to realise their full potential, along with any new antimicrobials, we need innovative pricing and reimbursement models to incentivise investment.
"By raising awareness of these challenges, we hope to ease the path towards implementation."
Other considerations and challenges highlighted in the review include:
- Low infection rates and limited public awareness of AMR make Australian trials difficult to conduct.
- While increasing in number, most NAM-based clinical trials globally are still in early stages, making it difficult to show the significance of NAMs’ potential benefits.
- The unique properties of NAMs will require consistent characterisation considerations for both manufacturing, regulatory guidelines.
- Updates to therapeutic goods guidelines could pave the way for a regulatory framework for nanomedicine to be established.
NAMs have the potential to be a crucial tool in the response to the AMR threat, if these hurdles can be overcome.
"Innovation and global collaboration are essential," said Dr Payne.
"We hope that early consideration of these factors will help to accelerate research translation, regulatory approval, and patient access to NAM therapies, not only in Australia, but globally."
The review is a collaboration between researchers from CSIRO, the University of Newcastle, Monash University and RMIT.
The review can found at An Australian perspective on clinical, economic and regulatory considerations in emerging nanoparticle therapies for infections.
Australia is experiencing a rising threat from AMR, where bacteria and other microorganisms can survive in the presence of drugs intended to eliminate them, such as antibiotics, largely due to over-exposure, commonly because of misuse or overuse.
AMR undermines the effectiveness of medicines and makes infections more difficult to treat.
A review published today in npj Antimicrobials and Resistance presents an Australian perspective on the potential of nano-antimicrobial (NAM) therapies to mitigate the impact of antimicrobial resistance (AMR) and highlights the scientific, regulatory, and manufacturing challenges that must be overcome to implement their use.
NAM therapies are part of the expanding field of nanomedicine, which utilises nanoparticles to prevent, diagnose, treat, and monitor diseases. Operating at the nanoscale (one nanometre equals one billionth of a metre), nanomedicine holds promise for treating diseases that are currently challenging or impossible to treat.
These therapies offer a promising approach to combating AMR by employing mechanisms not available to conventional antimicrobials. These mechanisms include targeted delivery of lower antimicrobial doses, disruption of drug-resistant biofilms, and direct inhibition of microbial growth.
Dr Jen Payne, co-lead author and researcher at CSIRO’s Manufacturing Research Unit, says that while NAM therapies, used in conjunction with existing antimicrobials, offer the potential to improve patient outcomes and combat rising antimicrobial resistance, they face similar market access and commercialisation challenges as other AMR solutions. These challenges, combined with manufacturing and regulatory obstacles, must be considered early in the design process to facilitate a smoother path to market.
"Nano-antimicrobial therapies represent a promising niche opportunity," Dr Payne said.
"But to realise their full potential, along with any new antimicrobials, we need innovative pricing and reimbursement models to incentivise investment.
"By raising awareness of these challenges, we hope to ease the path towards implementation."
Other considerations and challenges highlighted in the review include:
- Low infection rates and limited public awareness of AMR make Australian trials difficult to conduct.
- While increasing in number, most NAM-based clinical trials globally are still in early stages, making it difficult to show the significance of NAMs’ potential benefits.
- The unique properties of NAMs will require consistent characterisation considerations for both manufacturing, regulatory guidelines.
- Updates to therapeutic goods guidelines could pave the way for a regulatory framework for nanomedicine to be established.
NAMs have the potential to be a crucial tool in the response to the AMR threat, if these hurdles can be overcome.
"Innovation and global collaboration are essential," said Dr Payne.
"We hope that early consideration of these factors will help to accelerate research translation, regulatory approval, and patient access to NAM therapies, not only in Australia, but globally."
The review is a collaboration between researchers from CSIRO, the University of Newcastle, Monash University and RMIT.
The review can found at An Australian perspective on clinical, economic and regulatory considerations in emerging nanoparticle therapies for infections.