Melbourne, Australia and Cardiff, UK – 19 February 2019 – Medical Ethics Pty Ltd (“Medical Ethics” or “the Group”), a commercial and development company focused on pain mitigation in wounds for humans and animals, announces that the first patient has been successfully treated in the Company’s Phase IIa study of Tri-Solfen® (for human use the product will be branded as Medi-Solfen®) for the treatment of pain prior and post-surgical debridement of venous leg ulcers. This first-in-man study is being conducted at the Welsh Wound Innovation Centre in Wales, United Kingdom, with headline data expected in H2 2019.

Professor Keith Harding, Principal Investigator, Welsh Wound Innovation Centre, commented:
“We are pleased to initiate this important study looking at mitigating pain for patients with venous leg ulcers. The first patient was successfully treated, allowing the wound to be fully debrided without any reported sensation or pain. Pain associated with venous leg ulcers is a significant unmet need and I am excited by the potential of Medi-Solfen® in providing a convenient, safe and effective method of pain mitigation in such wounds. I look forward to delivering the full data following completion of the clinical trial.”

Allan Giffard, Managing Director of Medical Ethics, added:
“I am pleased to announce the successful treatment of the first patient with Medi-Solfen® in our Phase IIa clinical trial for the treatment of pain prior and post-surgical debridement of venous leg ulcers. This first-in-man trial is an important milestone for Medical Ethics, with Medi-Solfen® being our first product candidate for human use progressed for clinical development, as we move towards building a proprietary wound care and pain mitigation platform. We look forward to announcing headline data from the clinical trial in H2 2019.”

Medi-Solfen®, Medical Ethics’ lead product candidate for human use, is an innovative medicine designed to provide rapid onset and both short and prolonged analgesia effects for up to 24 hours. The topical gel contains two local anaesthetic agents and an antiseptic, and other active ingredients, designed to minimise bleeding and potentially protect against infection as well as promote healing.

The Phase IIa clinical trial will assess the safety and efficacy profile of Medi-Solfen® in providing anaesthesia when applied topically to venous leg ulcers, prior to and post-surgical debridement. The open, randomised, parallel group-controlled study is being conducted in 90 patients in three successive stages, which aims to study the time taken to achieve surface anaesthesia, degree of post-operative pain relief and patient’s assessment of overall quality as an anaesthetic during this procedure. Secondary objectives of the study include the duration and quality of post-operative pain relief following a single-dose, levels of anaesthesia achieved, and influence on the early healing trajectory of the leg ulcer.

Patients with venous leg ulcers report pain to be the worst aspect of having an ulcer, especially during debridement.1-4 Pain tolerated over a long time can cause a negative mood, decreased activities of daily living, sleep disturbance, reduced mobility and social withdrawal.5 In the UK alone, there are 278,000 venous leg ulcers being treated per annum, plus an additional 420,000 leg ulcers with no specific classification, however, it is broadly accepted that a number of these are venous in origin.6

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References

1. Lindholm, C., Bjellerup, M., Christensen, O. B. and Zederfeldt B. (1993) Quality of life in chronic leg ulcer patients. An assessment according to the Nottingham Health Profile. Acta Derm Venereol. Volume 73, issue 6, pp. 440-443.
2. Walshe, C. (1995) Living with a venous ulcer: a descriptive study of patients experiences. Journal of Advanced Nursing. Volume 22, issue 6, pp. 1092–100.
3. Phillips, T., Stanton, B., Provan, A. and Lew, R. (1994) A study of the impact of leg ulcers on quality of life: Financial, social and psychologic implications. Journal of American Academy of Dermatology. Volume 31, issue 1, pp. 49–53.
4. Moffatt, C. (2002) Pain at wound dressing changes. EWMA positioning document.
5. Franks, P.J. and Moffatt, C. (2001) Health related quality of life in patients with venous ulceration: use of the Nottingham health profile. Quality of Life Research. Volume 10, issue 8, pp. 693-700.
6. Guest J., Fuller, G.W., and Vowden P. (2018) Venous leg ulcer management in clinical practice in the UK: costs and outcomes. International Wound Journa;18:29-37l

Contacts:

Medical Ethics Pty Ltd
Allan Giffard, Managing Director
Charles Olsson, Marketing Director
Tel: +61 419 362 286

FTI Consulting
Brett Pollard / Victoria Foster Mitchell
Tel: +44 020 3727 1000

Notes for editors:

About Medical Ethics Pty Ltd
Medical Ethics Pty Ltd is a commercial and development company focused on pain mitigation in wounds for humans and animals. Our vision is to develop and deliver our proprietary highly effective, safe, affordable and practical pain relief platform to prevent pain and minimise suffering associated with wounds in humans, livestock and companion animals. Medical Ethics is focused on the development of the Group’s patented technology initially for the treatment of chronic wounds such as diabetic leg ulcers. Animal Ethics, a wholly owned subsidiary of Medical Ethics, is the first, and currently the only, company globally to develop, launch and commercialise a topical pain and wound management product for use in livestock undergoing painful husbandry procedures.

Further information

Medical Ethics:
Allan Giffard, Managing Director
Charles Olsson, Marketing Director
+61 419 362 286

FTI Consulting:
Brett Pollard, Victoria Foster Mitchell
+44 (0)20 3727 1000