Healome Therapeutics, an innovative biotech company based in Birmingham, has met a major milestone after the Medicines and Healthcare products Regulatory Agency (MHRA) approved a phase I trial for a scar-reducing wound dressing that uses the company’s technology.
The approval means that a new bioactive dressing, developed by University of Birmingham researchers and designed to reduce the scarring of skin burns, can now be trialled on 25 patients being treated at the Queen Elizabeth Hospital in Birmingham for heat burns that cover between 3% and 20% of their body. Scarred skin is often tighter, less flexible, and has an altered appearance and texture to normal skin. Scars can limit mobility and sometimes have knock-on impacts on how patients feel about their bodies.
In the UK, approximately 130,000 people visit A&E every year with burn injuries.1 These are both traumatic for patients and extremely expensive - the acute management of a major burn costs the NHS an average of £150,000 per patient.2 Burn injuries require complex wound management and are followed by hypertrophic skin scarring in as many as 72% of cases.3 This is a specific type of scarring that causes significant pain, restricts function and can require ongoing corrective surgery.
The choice of dressing is very important for optimising the environment for wound healing. Traditional wound dressings are designed to help heal burn injuries by providing a hydrating protective closure over the wound, and often have antimicrobial properties that help to minimise infection risk. Although these are effective at closing and healing wounds, none of the dressings currently on the market are designed to prevent or treat the post-burn scarring that follows these injuries.
The bioactive dressing is a clear film that combines the benefits of a traditional dressing with new features that help to reduce the risk of scarring. It does this by delivering a synthetic version of a protein called decorin, which is naturally found in humans and plays a key role in wound healing by reducing the inflammatory response and helping to organise new tissue as it is generated in the wound.
Early lab work indicated that the dressing may reduce tissue fibrosis and inflammation and encourage tissue regeneration. Healome has since developed materials capable of delivering and retaining decorin across the body as well as delivering microenvironments to guide healing. This trial will focus on a wound dressing format.
The research and development behind this innovation was funded by the Wellcome Trust and the Scar Free Foundation and was carried out at the University of Birmingham’s Healthcare Technologies Institute.
Healome owns the commercial rights to the underlying dressing technology and is exploring the formulation and delivery of a range of other therapeutics, having already attracted interest from a major wound care business. This is part of Healome’s wider work into engineering and delivering microenvironments that can include delivering existing drugs, and presents a huge number of commercial opportunities including licencing and direct to market routes.
Dr Richard Williams, Chief Executive Officer, Healome Therapeutics, said “We are delighted to have been given the green light by the MHRA for our first ever phase I clinical trial. This is a major milestone for the company that will demonstrate the safety of the dressing technology and be the first step towards evaluating how effective the decorin dressing is at healing wounds and reducing scarring.
"The trial will assess the product’s safety and early efficacy against another dressing commonly used by the NHS in the same type of wounds. This approval is excellent news not just for Healome but for all those stakeholders involved in funding the initial research and in supporting this project. We plan to use this trial to demonstrate what is possible in terms of drug delivery and use it as a platform to explore other innovative treatment options across wound care applications.”
References
- NHS standard contract for specialised burns care (all ages), Schedule 2 – The Services A. Service Specifications, 2013.
- S. J. Hemington-Gorse, T. S. Potokar, P. J. Drew, and W. A. Dickson, Burn care costing: the Welsh experience, Burns, vol. 35, no. 3, pp. 378–382, May 2009, doi: 10.1016/j.burns.2008.08.012.
- J. W. Lawrence, S. T. Mason, K. Schomer, and M. B. Klein, “Epidemiology and impact of scarring after burn injury: a systematic review of the literature.,” J. Burn care Res. Off. Publ. Am. Burn Assoc., vol. 33, no. 1, pp. 136–146, 2012, doi: 10.1097/BCR.0b013e3182374452.
