A novel solution for chronic

Wound
healing

Breakthroughs aren't incremental

Our new approach to chronic wound healing moves far beyond symptom treatment.

Our goal is to heal chronic wounds,

not just to treat them.

Incremental improvement to chronic wound treatment is insufficient. Each year, thousands of patients undergo preventable amputations as a result of ineffective wound management.

We believe that carefully designed and developed pharmaceutical products, such as our Advanced Therapy Medicinal Product AUP-16, will make the difference. Our new ATMP approach promotes healing of the wound by promoting tissue regeneration and releasing active biological therapeutic agents in-situ—within the wound itself.

Our therapy, AUP-16, is a topical treatment created using a genetically engineered Lactococcus lactis, a non-pathogenic probiotic bacteria. AUP-16 is produced under GMP conditions and analyzed using state-of-the-art methods to ensure identity, potency, consistency and safety. AUP-16 promotes healing by producing three therapeutic human proteins that i) improve immune cell activation and conversion to anti-inflammatory phenotype, ii) promote angiogenesis and iii) increase fibroblast proliferation and granular tissue formation.

AUP-16:

A four-in-one cell therapy

Lactococcus lactis is non-pathogenic bacteria that acts as a bioreactor in the tissue, producing human therapeutic proteins at the site of the wound. This is the same bacteria used in the production of cheese and buttermilk; AUP-16 takes advantage of this safe living vector to produce the following human proteins:

1

Fibroblast growth factor 2 (FGF2), a clinically used growth factor and signaling protein involved in cell proliferation and tissue repair.

2

Interleukin 4 (IL4), a potent anti-inflammatory M2 cytokine that promotes regeneration.

3

Colony stimulating factor 1 (CSF1), a hematopoietic growth factor involved in the proliferation, differentiation, and survival of monocytes, macrophages, and bone marrow progenitor cell

4
Lactococcus Lactis

Pre-clinical Results

show that application of AUP-16 in non-healing diabetic mouse wound models and in vitro human cell assays leads to:

Together, this four-in-one cell therapy targets multiple steps in the complex and compromised wound healing pathway. The therapeutic effect of a single protein or a single target molecule is often insufficient to result in healing, AUP-16 truly enables combination targeting in a single product.

Conversion of pro-inflammation to
anti-inflammation and regeneration
1
Increased angiogenic response
2
Granulation tissue formation
3
Faster epithelialization
4

Disease Applications

Our goal is faster and total healing of chronic wounds

The treatment of chronic, non-healing wound requires specialized wound care protocols and places a huge burden on the healthcare system. Aurealis Therapeutics’ AUP-16 is a clinically supported biotherapeutic medicine that goes beyond wound dressings and medical devices by halting the hostile inflammation and accelerating wound healing and tissue regeneration.1

Chronic wounds, unlike ordinary wounds, are severe and life-threatening. Each year 12 million patients globally develop a chronic wound. A staggering 1-2% of the world population will develop a chronic wound in their lifetime. With a 2-year mortality rate of over 30%, chronic wounds are claiming more lives than many types of cancer. The most common chronic wounds are diabetic foot ulcers, pressure ulcers, venous ulcers and arterial insufficiency ulcers. Chronic wounds are strongly associated with age and aged-related conditions like diabetes, obesity, and vascular disorders. Due to aging populations and the steep increase in diabetic patients and obese individuals, chronic wounds prevalence is rapidly increasing, over 10% per year. Typically, chronic wound patients have a drastically decreased life quality, suffering from chronic pain, infections, amputations, and disabilities. Moreover, between 25-50% of acute hospital beds are occupied by patients with chronic wounds. Chronic wounds account for 2-3% of total healthcare expenditure, which translates in more than $50 billion in the US alone every year. As a result, chronic wounds are a ‘silent epidemic’ that presents a major snowballing threat to public health and healthcare costs.
1

Diabetic Foot Ulcers

Diabetic foot ulcers (DFU) are non-healing wounds that are particularly difficult to treat. Approximately 435 million people live with diabetes worldwide, and up to 148 million will develop a diabetic foot ulcer in their lifetime.1,2 

DFU-related amputations result in substantial financial and quality of life costs. Wound care protocols and healing trajectory for DFU patients depend on the initial condition of the wound and whether additional complications are present. DFU recurrence or non-healing may be due to ischemia, or loss of vascularization or blood supply to the area around the wound. Chronic ischemia can require re-intervention or other measures to avoid infection and subsequent amputation. Even with comprehensive wound care, 23% of patients presenting critical limb ischemia (CLI) with diabetes will undergo an amputation within 12 months.3

Twenty percent of DFU infections require amputation, and it is estimated that 84% of all non-traumatic major amputations in diabetic patients are preceded by a DFU.4,5 It is critical that adequate care should be implemented early and incorporate a comprehensive wound management strategy, before amputation is unavoidable.
2

Venous Leg Ulcers and Pressure Ulcers

Venous leg ulcers are most typically appearing between the knee and ankle, often as open wounds prone to infection. They can develop after a minor injury, where persistently high pressure in the veins of the legs has damaged the skin. Estimated 1.6 million people suffer from venous ulcers in the EU and USA6 with 30% of patients not responding to the conventional therapy. Pressure ulcers, more commonly known as bed sores, are injuries to the skin and underlying tissue, primarily caused by prolonged pressure on the skin. They can happen to anyone, but usually affect people confined to bed or who sit in a chair or wheelchair for long periods of time. Pressure ulcers are painful for patients and costly to hospitals. For instance, pressure ulcer treatment in the UK makes up 4% of total NHS expenditure each year. 7
3

 

[1] Armstrong, David G., and Joseph L. Mills. “Juggling risk to reduce amputations: the three-ring circus of infection, ischemia and tissue loss-dominant conditions.” Wound Medicine 1 (2013): 13-14.

[2] Lazzarini PA, Pacella RE, Armstrong DG, van Netten JJ., 2018. Diabetes-related lower-extremity complications are a leading cause of the global burden of disability. Diabet Med. May 23. doi: 10.1111/dme.13680.

[3] Marston, William A., et al. “Natural history of limbs with arterial insufficiency and chronic ulceration treated without revascularization.” Journal of vascular surgery 44.1 (2006): 108-114.

[4] Lipsky BA, Berendt AR, Cornia PB, et al., 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012;54(12):1679-1684.

[5]  Barshes, N.R., Sigireddi, M., Wrobel, J.S., Mahankali, A., Robbins, J.M., Kougias, P. and Armstrong, D.G., 2013. The system of care for the diabetic foot: objectives, outcomes, and opportunities. Diabetic foot & ankle, 4(1), p.21847.

[6] Advanced Wound Care Market Forecast 2016-2026. Visiongain.

[7] Bennett G, Dealey C, Posnett J. The cost of pressure ulcers in the UK. Age Ageing. 2004 May;33(3):230-5. doi: 10.1093/ageing/afh086. PMID: 15082426.

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