Recce Pharmaceuticals has secured Australian ethics approval to expand its pivotal Phase 3 trial of RECCE 327 Topical Gel by adding a head-to-head study against antibiotics currently used to treat diabetic foot infections.
The Human Research Ethics Committee has approved an amendment to the Australian protocol that will introduce a randomised, active-controlled, non-inferiority study involving 208 participants with mild to moderate diabetic foot infections.
Participants will be randomised to receive either RECCE 327 Topical Gel, known as R327G, or a physician-selected comparator antibiotic. The approach is intended to generate comparative clinical data against established antibiotic options used in practice, rather than against a single uniform standard treatment.
Recce said there is no specific existing standard of care for diabetic foot infections, with treatment generally determined by the likely causative pathogen, antibiotic susceptibility, severity of infection, prior antibiotic exposure, allergy history and risk of methicillin-resistant Staphylococcus aureus. Antibiotic therapy may subsequently be adjusted based on culture and sensitivity findings.
Patient recruitment and dosing under the existing Australian Phase 3 protocol are already underway. The newly approved amendment will allow participants assigned to R327G to receive treatment for each qualifying diabetic foot infection experienced during the study, potentially enabling multiple efficacy assessments from an individual participant and expanding the volume of clinical data collected.
An independent data monitoring committee is expected to conduct an interim analysis once 104 participants have been enrolled, randomised, treated and either completed treatment or withdrawn from the trial.
The amended protocol will also introduce calibrated digital wound imaging. Recce said the imaging component is designed to provide standardised, objective wound measurements alongside investigator assessments, strengthening the evidence package intended to support future regulatory submissions.
The Australian program sits alongside Recce’s ongoing pivotal Phase 3 diabetic foot infection trial in Indonesia and forms part of a wider strategy targeting potential approvals in Australia, the United States, the Middle East and North Africa, and ASEAN markets.
Recce chief executive James Graham said the approval reflected continued momentum across the company’s Phase 3 programs and ongoing engagement from trial sites and clinicians.
He said the company was looking forward to generating comparative evidence for R327G against antibiotics used in routine care, while positioning the topical candidate as a potential future treatment option for diabetic foot infections.
