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NOx Pipeline


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NOx Pipeline


A DIVERSE PRODUCT PIPELINE

 

We are developing products for dermal/wound healing applications, respiratory and critical care, with our lead developments in chronic wound care.

  • ProNOx1, a Phase III study in 144 participants investigating the safety and efficacy of NOx in diabetic foot ulcers across sites in the UK. Results are being prepared for a high impact publication.
  • NOVAP, a Phase I dose finding study in ventilator associated pneumonia has demonstrated safe and effective delivery of NO by the NOx system.

NHS Research Ethics Committee approved studies:

  • ProNOx5, a Phase III study investigating the safety and tolerability of NOx in venous leg ulcers.
  • InNOvate, a Phase II randomised controlled transdermal drug delivery study.
  • ProNOx4, a Phase I study in microcirculation in septic shock.

NOx has demonstrated potent, broad-spectrum, anti-microbial activity.

Pre-clinical, data on file: NOx prevented biofilm formation, and was effective in treating established biofilms, for all antibiotic resistant and sensitive bacteria screened.

  • Bacteria screened included: P. aeruginosa and A. baumannii (antibiotic sensitive and multidrug resistant); E. coli (antibiotic sensitive); K. pneumoniae (resistant to many penicillin and cephalosporin antibiotics); and S. aureus (MSSA, MRSA and VISA).

Additional pre-clinical investigations are ongoing.

 
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Wound Treatment System


Wound Treatment System


Redefining Wound Care

 

Our revolutionary, disruptive, topical wound treatment system leverages the anti-microbial and healing properties of the NO pathway.

 
 

Our NOx wound treatment system uniquely provides a moist wound environment, which absorbs wound fluid, prevents infection, increases blood flow, and accelerates healing.

We believe this will significantly improve healing whilst reducing serious adverse outcomes, such as diabetes-related amputations.

 
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Diabetic Foot Ulcers


Diabetic Foot Ulcers


 
Diabetic Foot Ulcer.

DIABETIC FOOT ULCERS

“Every 30 minutes, a limb is lost due to a landmine. Every 30 seconds, a limb is lost due to diabetes”

Bharara et al. Int Wound J, 2009

Our most advanced developments are in diabetic foot ulcers. ProNOx1, our Phase III study investigating the safety and efficacy of NOx in diabetic foot ulcers, in 144 participants across sites in the UK is now closed, with results being prepared for a high impact publication.

 
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NOx TREATMENT


for chronic and acute wounds

NOx TREATMENT


for chronic and acute wounds

 

We are expanding the clinical evidence of NOx in chronic and acute wound care, with NHS Research Ethics Committee approved clinical studies approved and awaiting to start.


CHRONIC WOUNDS

The NOx wound treatment system provides a moist wound environment, while the hydrogel layer absorbs wound fluid, provides protection from further friction and pressure, and releases sustained NO to accelerate healing and prevent infection.

Venous Leg Ulcers

Approximately 2% of the population may experience venous leg ulcers in their lifetime – 60% of these ulcers take longer than 2 years to heal.

 

Leg Ulcers relating to Sickle Cell Disease

Leg ulcers can be a chronic, difficult-to-treat complication for patients living with sickle cell disease. In the US, approximately 100,000 people live with sickle cell disease, with up to 25% of these patients developing lower extremity ulcers.

The NOx wound treatment system is currently being used in a compassionate use programme.

 

Pressure Ulcers

There is a 33% incidence of pressure ulcers in critical care units, and 66% incidence amongst elderly patients admitted to acute care hospitals for non-elective orthopaedic procedures.


ACUTE WOUNDS

The NOx wound treatment system has been designed to be non-adherent over the wound bed, allowing for easy removal. Combined with its potent anti-microbial activity, there is a real opportunity to make a significant different in the acute wound care setting.

Burns

Approximately 6 million minor burns are treated medically each year worldwide.

Surgical Wounds

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There are approximately 100 million surgical incisions per year, and approximately 50 million traumatic wounds, with surgical site infection well recognised as a serious ongoing problem in the safe recovery and healing of wounds.

 
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Wound Dressing Platform


Wound Dressing Platform


 

Our NOx wound treatment platform, currently based on a highly absorbent sheet hydrogel, can be delivered on fibre, foam and hydrocolloid based dressings.

 
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DERMATOLOGY


DERMATOLOGY


MICRO-0RGANISM LED DERMATOLOGICAL CONDITIONS

 

The NOx system provides potent anti-microbial activity, with potential to enhance the local effects of systemic antibiotics and treat micro-organism led dermatological conditions.

Acne

Acne vulgaris, commonly caused by excessive growth of the bacteria Propionibacterium, is one of the top ten most prevalent diseases worldwide, affecting more than 630 million people worldwide.

Fungal nail infections (onychomycosis)

One of the hardest to treat superficial fungal infections, onychomycosis is a common dermatological condition affecting up to 26% people worldwide.

Atopic eczema (atopic dermatitis)

Atopic dermatitis is the most common form of eczema, a long- term skin disease, particularly prevalent in children, affecting 15-20% of children worldwide.

 
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TRANSDERMAL


drug delivery

TRANSDERMAL


drug delivery

TRANSDERMAL DELIVERY – ENHANCEMENT OF PASSAGE OF MOLECULES ACROSS THE SKIN BARRIER 

 

The number and efficacy of commercially available products for transdermal delivery is limited.

As well as stimulating local vasodilation, NO regulates intercellular adhesion and increases blood vessel permeability. We believe our NOx system will allow the transdermal application of large molecules that cannot currently be administered across the skin barrier.

Potential benefits include:

  • Avoiding pre-systemic metabolism that may occur following oral dosing, including both intestinal and hepatic first-pass metabolism.
  • Improving patient compliance by offering more convenient dosing regimens, such as once or twice weekly dosing.
  • The ability to quickly discontinue treatment by removal of the system.
 
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Critical & Respiratory


Critical & Respiratory


VENTILATOR ACQUIRED PNEUMONIA (VAP)

 

As the most prevalent nosocomial infection in Critical Care Units worldwide, VAP accounts for more than half of all Intensive Care Unit-acquired infections, with mortality rates ranging from 14-70%.

Our NOx system generates large amounts of NO, protecting the mucosal lining through its potent anti-microbial activities, and can be locally delivered to target tissues.

NOVAP, our Phase I dose finding study in mechanically ventilated patients demonstrated the safety of the NOx system and the ability to deliver NO to the stomach, oesophagus and mouth.

We propose that our NOx solution has the unique potential to prevent VAP by protecting the gastric and oropharyngeal colonisation from pathogenic bacteria, which would otherwise spread to the lungs.

 

SEPTIC SHOCK

 

Septic shock and severe sepsis occur as a result of infection and resulting organ dysfunction, with patients becoming critically unwell, requiring intensive care.  

Septic shock has been characterised by marked alterations of microcirculatory blood flow which, if a patient survives, can lead to permanent loss of limb function and extremity amputation, for example, as seen as a severe complication in paediatric meningitis.

We propose to use our NOx dressing system to increase local peripheral circulation to reduce the risk of limb damage. ProNOx4, our Phase I proof-of-concept study, assessing whether the NOx dressing system can improve peripheral circulation in patients with septic shock, is approved by the NHS Research Ethics Committee and awaiting MHRA approval

 

CYSTIC FIBROSIS

 

In the US, there are approximately 1000 new diagnoses of cystic fibrosis each year. The most common presentation of cystic fibrosis is with respiratory problems, usually recurrent lower respiratory tract infection with chronic sputum production.

We know from a previous healthy volunteer trial, RespiNOs, that we can deliver a safe, well-tolerated nebulised acidified nitrite to the lungs which then releases NO in situ. We also know that the NOx system is highly effective against Pseudomonas aeruginosa, the main pathogen responsible for lower respiratory tract infections.

The intrinsic properties of NO could have many beneficial effects, including enhancement of ciliary function and prevention of bacterial colonisation of the lungs, and therefore reduce symptoms of cystic fibrosis.