King's has been awarded a grant worth £2.7m to take OnchyMed - a "first-in-class" treatment for nail fungal infections - into clinical trials.
OnchyMed, an artificial nail containing a special gel, can kill nail fungus in just 24 hours and has no side effects. It holds potential to give relief to the millions of people affected by the disease and provides an alternative to the ineffective treatments currently available.
The grant, awarded by the National Institute of Health and Care Research (NIHR)'s Invention for Innovation (i4i) programme, will support a multi-disciplinary team led by Professor Stuart Jones, Director of the Centre for Pharmaceutical Medicine Research, to test the effectiveness and safety of the device in a phase II clinical trial.
I am delighted that the NIHR, through this funding, have recognised that it is important to develop new, effective therapies for nail infections. These infections are very persistent and impact millions of people worldwide, yet treatments are sadly limited. For vulnerable groups, such as people with diabetes or those with weakened immune systems, they can cause serious and potentially deadly issues."
Professor Stuart Jones, Director of the Centre for Pharmaceutical Medicine Research, King's
Professor Jones continued: "I am looking forward to working with my co-applicants to translate, this highly innovative topical therapy into clinical testing, which is an important step in this product's onward journey to the market."
Onychomycosis is a fungal infection of the nail thought to affect around 10% of the global population and up to 50% of older adults. It can be triggered by nail trauma (through playing sports), warm, moist environments, and older age. An infected nail is often brittle or crumbly and can have yellow, brown or white discolouration. It can lead to significant complication in people with comorbidities, including limb amputation for patients with diabetes.
While topical antifungal treatments for onychomycosis are currently available on the market, they have limited effectiveness due to their inability to properly penetrate the nail plate, which is one of the most difficult barriers in the body to get through. This means they must be used for between 6-12 months, which is the length of time it takes to fully grow a new, fungus-free nail. Prescribed medications taken orally are more effective at killing the fungus, but they have harsh side effects and are toxic to the liver and kidneys. Due to problems associated with current treatment options and the stubbornness of the disease, many people suffer with onychomycosis for years, if not decades.
OnchyMed, on the other hand, kills the fungus in just 24 hours and has no side effects as it does not enter the bloodstream. The device uses a well-known chemical compound called sodium hydrogen sulphide (NaHS). When NaHS is mixed with water, it releases hydrogen sulphide - a gas capable of destroying the fungus. For the device, NaHS is mixed with water to form a gel and placed under a plastic nail cover. It is kept stable and prevented from turning into a gas by being placed in vacuum-sealed packaging.
To use the artificial nail, an individual needs to remove it from its vacuum-sealed packaging and place it on their infected nail. As NaHS is a tiny molecule it can pass through the nail plate and spread through the nail to the nail bed. As it passes through the nail, the NaHS slowly turns into the gas hydrogen sulphide which kills the fungus. The gas is released in such tiny amounts that it is odourless.
The grant's co-applicants include a multi-disciplinary team of academics and clinicians from across King's and Guy's and St Thomas' NHS Foundation Trust (GSTT). They include Dr Mohamed Alhnan, Reader in Pharmaceutical Medicine, Dr Liz Clark, Visiting Lecturer and Patient Engagement Theme Lead, Dr Clare Heaysman, Senior Lecturer in MedTech Regulatory Affairs and Dr Wisam Alwan, Consultant dermatologist, Guy's and St Thomas' NHS Foundation Trust.
If successful, the trial will pave the way for the first clinically proven, fast-acting and non-invasive treatment for onychomycosis. The research team hopes to progress to larger clinical trials following the study, bringing the device a step closer to widespread clinical use.
