Recce Pharmaceuticals Limited (ASX:RCE), a leading developer of synthetic anti-infectives designed to address the urgent global health problems of antibiotic-resistant superbugs, announced on 19 August 2026 that it has received Human Research Ethics Committee (HREC) approval for an amendment to the protocol of its pivotal Phase 3 clinical trial of RECCE® 327 Topical Gel (R327G) for Diabetic Foot Infections (DFI) in Australia. This significant development expands the existing Phase 3 program by adding a new randomised, active-controlled, non-inferiority study arm.
The newly approved amendment will enrol 208 patients, randomised between R327G and one of four physician-selected comparator antibiotics. This head-to-head comparison against established DFI treatments is designed to generate crucial comparative clinical data, positioning R327G as a potential standard of care. There is currently no specific existing standard of care for DFIs, and successful outcomes could see R327G become the first designated treatment. Patient dosing continues under the existing trial protocol, with active recruitment and treatment progressing ahead of the new amendment’s full implementation.
Further enhancements to the protocol include amended inclusion criteria, allowing participants randomised to R327G to receive treatment for multiple DFI episodes, thereby increasing the volume and depth of efficacy data. The introduction of wound imaging using calibrated digital photography will also provide standardised, objective measurements, strengthening the data package for global regulatory submissions. This Australian Phase 3 program is a core pillar of Recce’s global development and regulatory strategy, reinforcing its ongoing pivotal Phase 3 DFI program overseas and targeting approvals across Australia, the United States, MENA, and ASEAN regions.
Recce Pharmaceuticals Chief Executive Officer, James Graham, commented, “This protocol amendment reflects the significant advancements being made in our Phase 3 Clinical Programs, with continued engagement from trial sites and clinicians. We look forward to patient dosing continuing and generating data for R327G against standard of care antibiotics. R327G has the potential to become the first standard of care used by physicians for the treatment of DFIs.”
