Edixomed: Breakthrough Wound Care Technology With Potential to Strike Back Against the Threat of Killer Superbugs

A simple patch which cleverly harnesses part of the body's own natural repair system - nitric oxide - could help in the fight against killer superbugs and antibiotic resistance according to recently published studies.

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Millions of people are at risk of dying from infections every day, many of which can no longer be treated by even the strongest antibiotics.

Now, in two recently published studies, a breakthrough wound care system, created by the UK firm Edixomed, has been shown to kill a range of antibiotic-resistant bacteria including MRSA and E. Coli, both of which have the potential to be fatal for many people.^[2],[3]  

The discovery could pave the way for these easy-to-use patches to be available in hospitals across the NHS to dress wounds to prevent the growth of bacteria, and tackle established infections.

"Bacterial infections resistant to all currently available antibiotics are expected to kill over 10 million people a year by 2050. The threat is very real and of international concern; but with this technology, we have a novel, viable and innovative solution with which to strike back. Wound care is just the first of many potential applications," said Professor Art Tucker, St Bartholomew's Hospital, London. He added, "Importantly, nitric oxide acts against multiple targets in bacteria to kill them, hence there is a very unlikely chance of bacteria developing resistance any time in the future."

In addition, Edixomed's breakthrough, the EDX110 wound care system, is able to deliver nitric oxide in a sustained way to give the wound or ulcer the best chance of healing. As part of the natural healing process the body normally produces nitric oxide and uses it to signal for increased blood flow and to fight infection. Edixomed's technology effectively "supercharges" the body's own natural healing processes.

In fact, recently published clinical research in diabetic foot ulcers, including infected ulcers, showed that the EDX110 patch achieved the same healing in 4 weeks as the standard-of-care approaches currently used in UK hospitals achieved at 12 weeks. The standard-of-care patients were also significantly more likely to be hospitalised due to complications with their foot ulcer.^[2]

"Diabetic foot ulcers are notoriously hard-to-heal and are the leading cause of diabetes-related amputations in the UK. The recently published findings provide an essential step forward in developing solutions for the effective management of these chronic wounds," said Professor Michael Edmonds, Principal Investigator of the pivotal diabetic foot ulcer study, King's College Hospital, London. He added, "Reducing infection and accelerating healing could significantly contribute to a reduction in the number of avoidable amputations. EDX110 represents a major step forward in best practice care."

In severe cases, infection of a foot ulcer in a patient with diabetes can result in lower limb amputation or worse e.g. complications such as sepsis, multi-organ failure and death.

Facts: 

• The NHS carries out more than 7,300 amputations each year in the UK as a result of diabetes, 80% of these are due to foot ulcers.^[4] The resulting drain on healthcare resources is enormous, with an annual cost of £1 billion to NHS England alone.^[5]
• At least 700,000 people die globally from drug-resistant infections every year - 5,000 of them in the UK.^[6],[7]
• There have been no new classes of antibiotics approved since the 1980s and the Chief Medical Officer, Professor Dame Sally Davies warned in 2017 that resistance to antibiotics "poses a catastrophic threat".^[8]

Key findings of the two recent studies investigating EDX110, a revolutionary new wound care system: 

• Laboratory tests have shown that EDX110 can kill all viable organisms for several deadly antibiotic-resistant infections including MRSA, Pseudomonas and E. Coli.^[3]
• Laboratory tests have shown that EDX110 effectively prevented and treated multi-drug resistant bacteria biofilms. Biofilms are colonies of bacteria that protect themselves from the body's immune system and actions of antibiotics.^[3]
• EDX110 completely healed more ulcers compared with standard-of-care (ulcers completely healed: 49% vs. 30%).^[2]
• EDX110 reduced diabetic foot ulcer size by almost double the amount of standard-of-care (median percentage area reduction: 89% vs. 47%).^[2]

About Edixomed 

Edixomed is a biopharmaceutical company commercialising next generation and clinically-proven technologies from its nitric oxide platform. Using its patented scientific approach, the company's technologies have the potential to tackle major global health challenges in wound care, dermatology and infection control. The core technology's unique feature is its ability to replenish or supplement the body's own supply of nitric oxide that is critical for sustaining healthy skin and organs. Nitric oxide is depleted or absent in many diseases and thus, the body's normal healing and regenerative processes are damaged. Restoring that essential element is at the heart of Edixomed's approach to innovative healthcare.

About EDX110 

EDX110 is a revolutionary, easy-to-use, two-part wound care system, driven by Edixomed's core sustained-release nitric oxide delivery technology. EDX110 provides a protective and cushioning layer that uniquely absorbs fluid while providing a moist environment and generating nitric oxide. The role of nitric oxide in ulcer healing involves three recognised elements: vascular, as nitric oxide influences the widening of blood vessels (vasodilation) and stimulates the growth of new blood vessels (angiogenesis);^[9],[10] inflammatory, as nitric oxide influences the body's immune response;^[11] and antimicrobial, as nitric oxide demonstrates potent, broad spectrum antimicrobial activity.^[12]

EDX110 is not yet an approved product, Edixomed are pursuing an active programme to develop applications of their core technology in multiple wound care indications and a number of additional areas. These areas include: surgical wound care, venous leg ulcers, pressure ulcers, burns, septic shock, transdermal drug delivery, ventilator-associated pneumonia, cystic fibrosis, and various applications connected to antimicrobial resistance.  

About nitric oxide 

The discovery that a simple gas, nitric oxide, could play such an important role in the human body led to three scientists being awarded the Nobel Prize for medicine in 1998. The pioneering work demonstrated that the normal function of nitric oxide is to control blood flow in the small vessels in the skin and prevent the skin from being infected with dangerous organisms. Nitric oxide is also generated whenever the skin is injured or damaged and plays a crucial part in the normal skin healing process. However, in certain conditions, such as diabetes, the normal production of nitric oxide can be put at risk and the skin loses the essential ingredient it needs to repair itself. The result is a chronic, poorly healing wound, highly prone to infection and a major cause of concern to patients and doctors. Replenishing the missing nitric oxide in such a way as to mimic the skin's natural production is no easy task and it has eluded many of the world's leading scientists for the past two decades. Edixomed has succeeded in achieving this goal and has demonstrated the performance of its technology in a pivotal clinical trial.

You can also visit our website at: http://www.edixomed.com

References 

1. Wired. If we don't act now, superbugs will kill us before climate change does. Available at: http://www.wired.co.uk/article/antibiotic-resistance-innovation-dame-sally-davies-nhs. Last accessed April 2018. 

2. Edmonds M. et al. Multicenter, randomized controlled, observer‐blinded study of a nitric oxide generating treatment in foot ulcers of patients with diabetes - ProNOx1 study. Wound Repair and Regeneration 2018. doi: 10.1111/wrr.12630 (https://doi.org/10.1111/wrr.12630). 

3. Waite RD, Stewart JE, Stephen AS, Allaker RP. Activity of a nitric oxide generating wound treatment system against wound pathogen biofilms. International Journal of Antimicrobial Agents. doi: 10.1016/j.ijantimicag (https://doi.org/10.1016/j.ijantimicag.2018.04.009).  

4. Diabetes UK. Twenty devastating amputations every day. Available at: https://www.diabetes.org.uk/about_us/news/twenty-devastating-amputations-every-day. Last accessed April 2018. 

5. NHS. National diabetes foot care audit report 2014-2016, England and Wales. 2017. Available at http://www.hqip.org.uk/public/cms/253/625/19/731/NDFA_2017_Report_PPT_Format_Final%20to%20HQIP.pdf?realName=vbKPm8.pdf&v=0. Last accessed April 2018. 

6. Gov.uk. Taking antibiotics when you don't need them puts you at risk. Available at: https://www.gov.uk/government/news/taking-antibiotics-when-you-dont-need-them-puts-you-at-risk. Last accessed April 2018.  

7. Review on Antimicrobial Resistance. Tackling drug-resistant infections globally. Available at: https://amr-review.org/sites/default/files/160525_Final%20paper_with%20cover.pdf. Last accessed April 2018. 

8. Daily Mail. 'We really are facing a post-antibiotic APOCALYPSE': Chief medical officer warns of the 'end of modern medicine' unless action is taken to create new drugs to tackle deadly superbugs. Available at: http://www.dailymail.co.uk/health/article-4976536/We-really-facing-post-antibiotic-APOCALYPSE.html. Last accessed April 2018. 

9. Ziche M, Morbidelli L. Nitric oxide and angiogenesis. Journal of neuro-oncology. 2000; 50: 139-48. 

10. Tucker A, Cooke ED, Pearson RM, Benjamin N. Effect of a nitric oxide generating system on microcirculatory blood flow in the skin of patients with Raynaud's Syndrome. Lancet 1999; 35: 1670-5. 

11. Guzik J. Nitric oxide and superoxide in inflammation and immune regulation. Journal of Physiology and Pharmacology. 2003; 54: 469-87. 

12. Fang F. Perspective series: host/pathogen interactions. Mechanisms of nitric oxide-related antimicrobial activity. The Journal of Clinical Investigations. 1997; 99: 2818-25. 

SOURCE Edixomed