• HREC approval for Phase 3 trial of RECCE® 327 Topical Gel (R327G) for DFI
• Expanded eligibility to include Moderate DFI patients
• Study now includes infected ulcers below the knee, enhancing study power
• Two parallel Phase 3 programs in Australia and Indonesia

Recce Pharmaceuticals Ltd has announced that the Human Research Ethics Committee (HREC) has approved a protocol amendment to its Phase II clinical trial of RECCE® 327 Topical Gel (R327G) for the treatment of Diabetic Foot Infections (DFI), advancing the study to a Pivotal Phase 3 clinical trial. This approval builds upon the previously completed Phase II ABSSSI/DFI clinical trial that successfully achieved a 93% primary efficacy endpoint at Day 14 and 86% clinical response by Day 7, with no serious adverse events reported. The HREC-approved protocol amendment expands eligibility to include Moderate DFI patients in addition to Mild DFI patients, significantly broadening the recruitment patient population for R327G. Given R327G's favorable safety profile, the study has also been expanded to include infected ulcers below the knee, enabling an additional primary endpoint analysis at the individual ulcer level, increasing study power and enhancing the probability of success.