First product candidate for human use progressed for clinical development

Marks an important milestone towards building a proprietary wound care and pain mitigation platform

Melbourne, Australia – 17 December 2018 – 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 UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved its application for a Phase IIa clinical trial of Tri-Solfen® (for human use the product will be branded as Medi-Solfen®)  for the treatment of pain during the surgical debridement of venous leg ulcers.

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 will be conducted in 90 patients in three successive stages, which aim 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 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. We anticipate initiating the clinical trial in Q1 2019.

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

Allan Giffard, Managing Director of Medical Ethics, commented:
“We are thrilled to announce the MHRA approval of our Phase IIa clinical trial design for Medi-Solfen® for the treatment of pain during the surgical debridement of venous leg ulcers. The application is based on an extensive body of evidence, which demonstrate the potential of Medi-Solfen® in providing a convenient, safe and effective method of pain mitigation in wounds and we look forward to investigating this further in venous leg ulcers, where there is a significant unmet patient need. This approval is an important milestone for Medical Ethics, with Medi-Solfen® being our first product candidate for human use progressed for clinical development and as we move towards building a proprietary wound care and pain mitigation platform.”

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

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Contacts:
Medical Ethics Pty Ltd
Allan Giffard, Managing Director
Charles Olsson, Marketing Director

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.

About Tri-Solfen^® (to be known as Medi-Solfen^® in humans)
Medi-Solfen^® is a local anaesthetic and antiseptic gel. Medi-Solfen^® contains two proven topical local anaesthetics; fast-acting Lidocaine for immediate pain relief and long-acting Bupivacaine for prolonged post-operative pain relief. Adrenaline is included for its ability to reduce the shock and stress of blood loss, whilst prolonging the anaesthetic action. Medi-Solfen^® also contains Cetrimide; an antiseptic widely used to cleanse skin and wounds and provides protection from bacterial contamination.

For further information, please visit http://medicalethics.me