Despite its growing threat to global health, research aimed at tackling antimicrobial resistance (AMR) has been constrained for many years, most likely due to the rapid evolution of resistance in pathogens, regulatory and policy barriers, and high research and development (R&D) costs.
Withers & Rogers
However, recent developments have led to a growing belief that viable solutions to this pressing global health issue may be within reach. Georgia Mann, senior associate, Withers & Rogers discusses.
The World Health Organisation (WHO) has identified AMR as one of the most serious global health threats. In 2019 alone, bacterial AMR directly caused an estimated 1.27 million deaths and was associated with a further 4.95 million deaths worldwide. Additionally, an independent review on AMR carried out by Lord Jim O’Neill on behalf of the UK Government in 2016 stated that if urgent action is not taken, drug-resistant infections could claim up to 10 million lives annually by 2050 and could cost the global economy a cumulative $100 trillion.
Several governments have taken steps to address antimicrobial resistance (AMR), with some introducing dedicated national strategies. For instance, the UK Government launched the world’s first subscription payment model in 2020, as part of a 20-year vision to tackle AMR. Under this model, the NHS pays a fixed annual fee of £10 million each to Pfizer and Shionogi for access to their antibiotics - Zavicefta and Fetcroja - regardless of how much is used. These drugs are reserved for treating patients with severe, drug-resistant infections. The Global AMR Innovation Fund (GAMRIF) is another UK government initiative, which invests in early-stage research in areas of antimicrobial resistance (AMR) that are typically underfunded, with a focus on delivering benefits to populations in low- and middle-income countries (LMICs). GAMRIF collaborates with a diverse range of partners through bilateral agreements, global research initiatives, and product development partnerships.
Whilst it’s encouraging to see progress in the fight against antimicrobial resistance (AMR), the lengthy process of discovering and developing new antimicrobials, along with conducting clinical trials and navigating regulatory approvals, continues to slow momentum. However, recent breakthroughs offer renewed optimism.
For example, a team of researchers in Israel has uncovered a previously unrecognised immune mechanism in which proteasomes generate antimicrobial peptides in response to bacterial infection. Published in Nature, the study reveals a novel role for proteasomes, traditionally known for protein degradation, in host defence. By producing these natural antibacterial peptides, proteasomes contribute directly to innate immunity, offering a promising new avenue for the development of therapies targeting antibiotic-resistant infections.
In addition, scientists have hailed gepotidacin as the first new antibiotic treatment for gonorrhoea in over 30 years, offering a promising tool against rising drug resistance. In a Phase III trial led by UK and US researchers and involving over 600 patients across six countries, the oral treatment was found to be as effective as the current standard, and successful against resistant strains. The Phase III results have been published in The Lancet, with findings suggesting that gepotidacin could enhance patient experience and help reduce the healthcare burden. However, further research is needed to assess its effectiveness across different populations and infection sites.
A company actively advancing the development of innovative antimicrobial agents to address the urgent challenge of drug-resistant infections is MetalloBio. Their focus is on creating a novel class of antimicrobial compounds that show promise against both Gram-negative and Gram-positive bacteria. Backed by patent protection, public crowdfunding, and strong support from the scientific community, MetalloBio is advancing a promising therapeutic platform that could contribute significantly to the global fight against antimicrobial resistance.
In parallel with the development of novel therapeutics technologies are increasingly driving progress in the fight against antimicrobial resistance (AMR). One of the most promising advancements is the use of artificial intelligence (AI) in drug discovery. AI is being harnessed to analyse vast datasets, uncovering potential drug candidates and identifying opportunities to repurpose existing treatments. This data-driven approach not only accelerates the development of new therapies for drug-resistant infections but also significantly reduces the time and cost involved. By revealing hidden patterns and predicting how molecules interact, AI is poised to play a transformative role in addressing the urgent global need for effective antimicrobial solutions.
Innovations in diagnostics are also essential in the fight against antimicrobial resistance, as they enable rapid and precise identification of infections, helping to guide appropriate treatment and reduce the misuse of antibiotics. In a bid to accelerate the search for solutions, some innovators have been looking for new diagnostic tools and methods, which could help to prevent overuse of broad-spectrum antibiotics. Overuse of this useful and diminishing group of drugs can contribute to antibiotic resistance, making infections harder to treat. For example, bioMérieux, a global leader in the field of in vitro diagnostics, acquired BioFire Diagnostics in 2014, with a comprehensive global patent portfolio (including EP3401422B1) directed toward rapid PCR systems, methods, and pathogen panels. BIOFIRE systems and panels provide highly sensitive and specific pathogen diagnostics, distinguishing bacterial, viral, yeast and parasitic pathogens, and identifying the presence of antimicrobial resistance genes, for optimised treatment of infections. Additionally, DEWACT LABS GMBH have obtained patent protection for a diagnostic method and device that uses specific biomarkers to differentiate between viral and bacterial infections. It focuses on detecting proteins such as Mx GTPases (associated with viral infections) and C-reactive protein (CRP) (associated with bacterial infections).
Another promising area of innovation focuses on treatments that can counteract bacterial resistance mechanisms. Early-stage research has identified 'resistance breakers', which are compounds that can prevent or reverse antibiotic degradation. For instance, co-administration of beta-lactamase inhibitors with beta-lactam antibiotics can neutralise the beta-lactamase enzymes produced by certain bacteria, thereby restoring the effectiveness of beta-lactam antibiotics. In parallel, there is growing interest in bacteriophages, which are viruses that specifically infect bacteria by injecting their genetic material, with lytic phages ultimately causing the bacterial cells to rupture. While primarily explored for therapeutic use, ongoing research is investigating broader applications of phage technology in combating antimicrobial resistance. For example, Armata Pharmaceuticals has secured patent protection for a method of treating human infections caused by Staphylococcus aureus using a composition containing one or more targeted bacteriophages that are capable of infecting and lysing S. aureus. The company has also obtained patent protection for the bacteriophage composition itself.
With the surge in scientific research aimed at tackling antimicrobial resistance (AMR), it is crucial that innovators integrate intellectual property (IP) strategy into their development plans from the outset. While the excitement of early breakthroughs can make it tempting to share findings publicly, especially in such a high-profile field, premature disclosure can jeopardise the ability to secure patent protection. In addition to patents, innovators should also consider the strategic use of trade secrets and know-how. For instance, maintaining certain aspects of an innovation as a trade secret can provide long-term competitive advantages, provided that appropriate confidentiality measures are in place. Involving IP professionals early in the innovation journey is extremely important. It helps researchers make informed decisions about what to patent, what to keep confidential, and how to build an IP portfolio that supports long-term commercial goals. Keeping track of global patent activity can also reveal trends in emerging technologies, highlight potential collaborators or competitors, and help ensure freedom to operate. In a fast-moving and competitive field like AMR, a comprehensive IP strategy that includes patents, trade secrets, and technical know-how can significantly enhance the reach and commercial potential of innovation.