OnchyMed: A First In Class Medical Device For Onychomycosis

Research question Is topical hydrogen sulphide administered using an artificial medicated nail safe and effective against onychomycosis after only two consecutive 24 h treatments? Background Onychomycosis has a prevalence of 10% in the general population, which rises to 50% in those aged over 70 years. It results in morbidity, including a significant impact on quality of life, limb amputation in patients with diabetes, and high foot care costs, especially for older adults. The current treatments comprise oral systemic antifungal therapy, topical antifungal therapy, and medical devices. However, these approaches only successfully cure the disease in about one-half to one-third of those treated and need 4-12 months of therapy. The high prevalence of onychomycosis and the inadequacies in the current approaches are leading to an alarming increase in treatment-resistant infections. Together, these elements make onychomycosis a significant unmet clinical need. Aims and Objectives This project aims to generate clinical evidence that OnchyMed, a hydrogen sulphide-loaded artificial nail, safely and effectively treats onychomycosis after two consecutive 24-hour applications over two days. The following objectives will be completed to achieve the project aim: 1. Finalise the device design through user testing and formal risk assessment processes. 2. Produce a sodium hydrogen sulphide-loaded artificial nail with appropriate quality and shelf-life data for clinical testing. 3. Prepare the technical documentation required for regulatory compliance of the drug-device combination. 4. Conduct a phase 2a clinical trial to confirm the drug-device combination's safety and efficacy. 5. Complete a full economic and healthcare technology assessment to allow successful licensing and healthcare adoption of the product. Methods To finalise the device design, we will complete usability assessments in onychomycosis patients, build the device design file in a quality management system, and complete device verification, biological safety and risk assessment. We will work with an MHRA-audited facility to combine the artificial medicated nail with the sodium hydrogen sulphide medicinal product in packaging, allowing at least 12 months of stability under a suitable quality system to enable clinical testing. We will complete a double-blind, phase 2a, randomised clinical study of the OnchyMed in 40 onychomycosis patients. We will develop economic tools to evaluate the new approaches' cost-effectiveness and commercial headspace. This modelling, with a competitor analysis and adoption strategy, will be combined with the clinical data to provide a commercial package for licensing and further phase 3 clinical development. Timelines for delivery This three-year project will progress the development of OnchyMed from the current pre-clinical stage (TRL4) to the completion of phase 2a clinical testing (TRL6). Anticipated Impact and Dissemination The project will provide evidence that OnchyMed is a highly effective "first-in-class" approach to treat onychomycosis. When it reaches the market, OnchyMed will improve patient outcomes and dramatically reduce healthcare costs of onychomycosis through its enhanced efficacy, rapid treatment, increased compliance, reduced side-effects and reduced need for additional healthcare interventions. The results of the work will be disseminated through scientific publications, international conferences, the media, and clinical and patient networks.