Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has received approval from the human research ethics committee (HREC) to kick off its Phase I/II clinical trial assessing RECCE® 327 as a spray-on, broad-spectrum antibiotic therapy for mild skin and soft tissue diabetic foot infections (DFI).
The Phase I/II clinical trial is a single-centre, prospective, interventional study assessing the safety and efficacy of R327 as a broad-spectrum, topical anti-infective treatment for patients with mild skin and soft tissue DFI.
The trial will enrol up to 32 patients and will be conducted at Sydney South West’s limb preservation and wound research unit, renowned for its innovative and ground-breaking focus on wounds of the limbs and limb loss, an under-researched area in Australian healthcare.
Moving forward, with the patient population readily available, Recce expects the first patients to be dosed by the March quarter of 2023.
"Yet another milestone"
Recce chief executive officer James Graham said: “Receiving HREC approval is yet another milestone for Recce and the clinicians seeking to find an effective therapeutic treatment against DFI.
“This achievement speaks to Recce’s track record of HREC approvals already received and the dedication of our clinical and research team, as we look forward to building out our topical programs.”
Study highlights
The clinical investigation team comprises Professor Hugh Dickson OAM as principal investigator (Consultant Physician in Ambulatory Care), associate professor Slade Jensen (Chair of Infectious Diseases and Microbiology and Western Sydney University, School of Medicine), a team of specialist associate investigators and the Ingham Institute of Applied Medical Research.
Recce is exploring R327 as a preventative treatment for DFI, as studies in the United States have shown between 14-24% of patients with diabetes who develop a foot ulcer will require an amputation, and foot ulceration precedes 85% of diabetes-related amputations.
The study is made possible thanks to the NSW Government Department of Health, at a cost of A$500,000.
Dickson said: “The research indicates that RECCE® 327 may be effective in treating patients with diabetic foot infections.
“The team hopes that its early promise is fulfilled in this study in our patients.”
Forward plan
Ethics approval for this clinical trial is confirmation that the company has completed the necessary pre-clinical safety and efficacy testing of R327 required to commence human clinical trials and runs in addition to its other ongoing clinical trials.
Investigators will review the study data for clinical efficacy and toxicity before deciding to expand the trial to assess the compound’s efficacy against the current best standards of care.
About RECCE® 327
Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives with RECCE® 327 being an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to gram-positive and gram-negative bacteria including their superbug forms.
It has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world’s only synthetic polymer and sepsis drug candidate in development.
The anti-infective is not yet market-approved for use in humans with further clinical testing required to fully evaluate safety and efficacy.