Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has welcomed the unanimous approval by an Independent Safety Committee to expand the Phase 1/2 clinical trial for its diabetic foot infection treatment, RECCE® 327.
Safety, tolerability and efficacy
This decision follows a promising interim data analysis showcasing the treatment's safety, tolerability and efficacy in resolving bacterial infections in diabetic foot ulcers.
The ongoing trial, which has met its primary endpoints, is set to broaden its reach, with additional sites in Australia and future international trials planned.
RECCE® 327, applied either daily or every second day over a 14-day period, has shown promising results in treating these complex infections, which are of significant concern for the diabetic community.
Following a comprehensive review, Liverpool Hospital NSW's Independent Safety Committee confirmed the trial's success in achieving its safety and efficacy goals, prompting a wider inclusion criterion for patient participation.
This will extend the potential benefits of Recce’s asset to a larger patient group, managed through the Ingham Institute for Applied Medical Research.
Foot ulcers common for diabetics
Diabetic foot ulcers are a common complication affecting 19% to 34% of the global diabetic population and significantly increase the risk of severe outcomes like limb amputation.
The trial's expansion represents a big step towards offering a non-invasive treatment option for this debilitating condition.
Professor Hugh Dickson, director of Ambulatory Care at Liverpool Hospital and principal investigator of the trial, said, “I am greatly encouraged by the speed at which my patients’ Diabetic Foot Ulcer infections have responded to R327 when applied topically.
Devastating consequences
“A non-invasive method to treat the burdensome challenges of diabetic foot ulcer infections gives hope to better patient outcomes and avoid limb amputation as is so commonly the case with these complicated patients.
“We thank the independent committee's recognition of the many world-firsts taking place in this DFI clinical trial and welcome expanded access to patients both here at Liverpool Hospital and medical settings beyond.”
Recce Pharmaceuticals CEO James Graham said: “We are pleased with the decision of the independent committee. We look forward to seeing the potential of R327 utilised as a treatment option in patients suffering from DFIs, offering a chance at a better quality of life without the devastating consequences of amputation.”
As the trial progresses, Recce Pharmaceuticals aims to leverage these findings to further the development and accessibility of RECCE® 327 as a vital treatment option for those suffering from diabetic foot infections.