Diabetes Mellitus is one of the fastest growing medical conditions. In the United States alone, more than 34 million Americans were living with diabetes in 2020, and worldwide around 500 million people are estimated to have the disease.
Diabetic Foot Ulcers (DFU) are a common complication of diabetes because the frequently reduced peripheral blood supply (ischemia) as well as damage of peripheral nerves (neuropathy) facilitate the development of diabetic foot ulcers. The lifetime risk of people with diabetes developing a foot ulcer is 34% and every year about 1.8 million people in the US develop a diabetic foot ulcer.
One major complication that also carries a high risk for even more significant complications is an infection of the diabetic foot ulcer. About 50% of all foot ulcers get infected at some point and in many cases, these infections (about 20%) lead to an amputation. Every infection starts as a mild infection, which if either untreated or insufficiently treated, can transition into a more severe infection which then may lead to hospitalization and potentially to amputations. This underlines the importance of detecting infection early (mild) as well as of effective treatment options including those that are effective against the increasing number of infections caused by resistant bacteria (e.g., Methicillin Resistant Staphylococcus aureus – MRSA). In addition to the strong medical need, the fact that $176 billion is spent annually on direct costs for diabetes with one-third of that for lower extremity complications underlines as well as the health-economic importance.
Lakewood-Amedex has conducted two clinical trials with the lead compound Nu-3 as a solution formulation. A Phase I skin toleration trial demonstrated the compound to be safe with minimal to no skin sensitization. A follow-on Phase 2 trial in infected diabetic foot ulcer (DFU) also demonstrated that the solution formulation was safe. In addition, the 2% solution consistently pointed to a trend for positive effects on both infection and wound healing. Lakewood-Amedex has chosen to switch the formulation and develop a gel that will improve residence time at the site of infection as well as increase the dose that can be explored in the clinic.
The Company has recently received clearance from the FDA to conduct a Phase 2 clinical trial using a 5% and 10% gel formulation of Nu-3 in mildly infected diabetic foot ulcers (iDFU) to demonstrate safety and efficacy in reducing the bacterial load in the infected ulcers. This trial is designed as a double-blinded, randomized, and placebo-controlled dose comparative study and is planned to enroll about 60 patients and multiple study sites in the US. For more information see Nu-3 Gel for Infected Diabetic Foot Ulcers – Full Text View – ClinicalTrials.gov.