Recce Pharmaceuticals expands Phase 3 trial for diabetic foot infection gel

Recce Pharmaceuticals has received Human Research Ethics Committee (HREC) approval for a protocol amendment to its Phase 3 clinical trial of RECCE 327 Topical Gel (R327G) in Australia. The gel is being developed to treat Diabetic Foot Infections (DFI).

The amendment expands the existing program by adding a randomized, active-controlled, non-inferiority study arm. This new arm will enroll 208 patients to compare R327G against four physician-selected comparator antibiotics. The goal is to generate comparative clinical data to position R327G as a potential standard of care for DFIs, a condition that currently lacks a specific designated treatment.

Additional enhancements to the trial include amended inclusion criteria that allow participants to receive treatment for multiple DFI episodes and the introduction of wound imaging via calibrated digital photography to provide objective measurements. This Australian program supports Recce’s broader global strategy to seek regulatory approvals in the United States, MENA, and ASEAN regions.