Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has dosed patients in a Phase I/II diabetic foot infection (DFI) clinical trial, testing the safety and efficacy of RECCE® 327 (R327).
R327 has a universal mechanism that allows its compounds to continuously kill bacteria and multi-drug resistant superbugs and is one of the first new classes of antibiotics in more than 30 years.
The clinical trial at Liverpool Hospital's South West Sydney Limb Preservation and Wound Research Unit will see patients dosed daily over 14 days to assess the safety and efficacy of R327 as a broad-spectrum topical anti-infective treatment for patients with mild skin and soft tissue diabetic foot infections.
It is the largest DFI study underway in Australia at this time and interim data readouts are expected later this quarter of patients dosed with R327 as a topical administration.
Common in diabetes
Each year Liverpool Hospital’s high-risk foot service manages around 800 patients presenting with complex foot disease, with more than 80% occurring in people with diabetes.
The study is supported by outpatient nurses who are trained in R327 diabetic foot infection treatment protocols, to ensure daily dosing and wound health, while capturing a broadened patient population.
Diabetes is the leading cause of non-traumatic lower extremity amputations in the United States, with a reported 14-24% of diabetic patients who develop a foot ulcer requiring amputation. Furthermore, foot ulcers are behind 85% of all diabetes-related amputations.
The cost of treating diabetic foot diseases in the US is said to be US$9-US$13 billion ($14-$20.3 billion) every year.
Recce Pharmaceuticals CEO James Graham said: “R327 topical dosing of multiple patients in Australia’s largest [DFI] study is another welcomed advance to the company’s infectious disease portfolio of clinical programs.”