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UK Biotech, Edixomed, Develops Breakthrough Technology That Doubles Healing Rate Of Chronic Infected Diabetes-Related Ulcers

Edixomed
Posted on: 06 Apr 18

UK Biotech, Edixomed, Develops Breakthrough Technology That Doubles Healing Rate Of Chronic Infected Diabetes-Related Ulcers

 

Wednesday 4 April 2018, London, UK New results published today show that Edixomed’s revolutionary new wound care system, EDX110, can heal diabetic foot ulcers dramatically faster and more effectively than current standard care.[1] “Diabetic foot ulcers are notoriously hard to heal, and are the leading cause of diabetes-related amputations in the UK. The findings reported today provide an essential step forward in developing solutions for the effective management of these chronic wounds,” said Professor Michael Edmonds, Principal Investigator, King’s College Hospital, London. “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.”

 

EDX110 provides a protective and cushioning layer that uniquely absorbs fluid while providing a moist environment and generating nitric oxide. The findings of this study support the unique potential of EDX110’s core technology: a sustained-release nitric oxide generating platform, that can be delivered as a dressing, liquid, gel or inhaled spray, with potential application in a variety of serious, underserved conditions and public health challenges, such as antimicrobial resistance (AMR).

 

Results from the pivotal clinical study, conducted in major UK treatment centres and involving 148 diabetic foot ulcers, showed that in 12 weeks, EDX110 reduced ulcer size by almost double the amount standard-of-care achieved (89% vs. 47%). EDX110 also increased the number of completely healed ulcers by more than 50% (49% vs. 30%), nearly doubled the complete healing of infected ulcers (45% vs. 23%) and significantly reduced hospitalisations and serious adverse events related to the ulcer, compared with standard-of-care at 12 weeks.1

 

Through its novel mode-of-action, Edixomed’s unique technology safely harnesses a key molecule in the body’s own defences, nitric oxide, to amplify the body’s own response in fighting infection, improving healing and potentially increasing the activity of any prescribed antibiotic. Laboratory tests have shown EDX110 rapidly and safely kills bacteria, viruses and fungi, including several deadly antibiotic-resistant infections, such as MRSA and E. Coli.[2],[3]

 

“Infections resistant to all currently available antibiotics are expected to kill 10 million people a year by 2050. The threat is very real but with this technology, we have a viable and innovative solution to strike back with, and wound care is just the first of many potential applications of this new technology” said Professor Art Tucker, St Bartholomew's Hospital, London.

 

Professor Chris Wood, Chief Medical Officer, Edixomed, added, “We are excited by the results we have seen in the clinic and lab, and are working to maximise the potential benefit to as many patients as possible, as quickly as possible. Edixomed has developed a completely new, important solution to the problem of chronic wound care and the major issue of antimicrobial resistance. This is a powerful and versatile core technology with many potential applications,  and we are actively pursuing a global strategy in partnership with leading innovation, clinical and distribution networks, to maximise the impact of this potentially disruptive technology.”

 

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, 2-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 (vasodilatation) and stimulates the growth of new blood vessels (angiogenesis);[4],[5] inflammatory, as nitric oxide influences the body’s immune response;[6] and antimicrobial, as nitric oxide demonstrates potent, broad spectrum antimicrobial activity.[7]

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

 

About the EDX110 clinical study                              

In the pivotal EDX110 clinical study, a “real world” wound care population was studied, including participants with ulcers complicated by infection. Prior to the EDX110 study, there has been growing concern that results from many randomised controlled trials cannot be generalised to the “real world” wound care population and that there had been a lack evidence for advanced wound dressings in diabetic foot ulcer management in “real world” settings.[8],[9],[10]

 

 

 

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 proven the performance of its technology in a pivotal clinical trial.

For further information please contact:

Martine Morris: Media Relations (+44(0) 7939 801100 / martinemorris@edixomed.com)

Carl Daintree: Chief Operating Officer (carldaintree@edixomed.com)

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

 

References

 

[1] Edmonds M. et al. Multicenter, randomized controlled, observerâ€Â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.

[2] Sellars LE, et al. An assessment of the antimicrobial activity of a novel, nitric oxide generating wound treatment system according to the modified AATCC test method 100. Poster presentation at Wounds UK Annual Conference 2017.

[3] Waite R, et al. Activity of nitric oxide generating dressing system against wound biofilms. Poster presentation at the 5th European Congress on Microbial Biofilms, Eurobiofilms 2017.

[4] Ziche M, Morbidelli L. Nitric oxide and angiogenesis. J Neurooncol 2000; 50: 139–48.

[5] 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.

[6] Guzik J. Nitric oxide and superoxide in inflammation and immune regulation. J Physiol Pharmacol. 2003; 54: 469–87.

[7] Fang F. Perspective series: host/pathogen interactions. Mechanisms of nitric oxide-related antimicrobial activity. J Clin Invest. 1997; 99: 2818–25.

[8] Game FL, Apelqvist J, Attinger C, Hartemann A, Hinchcliffe RJ, Londahl M, et al. IWGDF Guidance on the use of interventions to enhance the healing of chronic ulcers of the foot in diabetes. Updated 2015. http://iwgdf.org/guidelines/guidance-on-wound-healing-2015-2/ (accessed May 8, 2017).

[9] Wu L, Norman G, Dumville JC, O’Meara S, Bell-Syer SE. Dressings for treating foot ulcers in people with diabetes: an overview of systematic reviews. Cochrane Database Syst Rev 2015; 7: CD010471.

[10] Carter MJ, Fife CE, Walker D, Thomson B. Estimating the Applicability of Wound Care Randomized Controlled Trials to General Wound Care Populations by Estimating the Percentage of Individuals Excluded from a Typical Wound Care Population in Such Trials. Advances in Skin & Wound Care. 2009; 22: 316–24.

For more information:
www.edixomed.com

Editor's Details

Sophie Purvis
Arc Bio Communications
www.arcbiocomms.com
+44 (0) 207 801 6348
slp@arcbiocomms.com

Last updated on: 06/04/2018

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