Recce Pharmaceuticals Ltd announces it has received Human Research Ethics Committee (HREC) approval to start its Phase 1/2 trial assessing RECCE 327 as a spray-on, broad-spectrum anti-infective therapy for mild skin and soft tissue diabetic foot infections (DFI).
“The research indicates that RECCE 327 may be effective in treating patients with diabetic foot infections,” said Professor Dickson, Principal Investigator of the Phase 1/2 study. “The team hopes that its early promise is fulfilled in this study in our patients.”
James Graham, Chief Executive Officer of Recce Pharmaceuticals, added, “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.”
The clinical investigation team is comprised of 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.
The Phase 1/2 single-center, prospective, interventional study is designed to assess the safety and efficacy of R327 as a spray-on, broad-spectrum anti-infective therapy for patients with mild skin and soft tissue DFIs. The trial will enroll up to 32 patients and be conducted at Sydney South West’s Limb Preservation and Wound Research Unit. This unit was chosen for its innovative and ground-breaking focus on limb wounds and loss, an under-researched area in Australian healthcare. Sydney’s South West also has one of the highest prevalence rates of diabetes in North South Wales (NSW), and complications from this disease can significantly impact people’s quality of life. The Company expects the first patients to be dosed in Q1 2023.
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 R327’s efficacy against the current best standards of care.
[Source(s): Recce Pharmaceuticals, Globe Newswire]