Recce Pharmaceuticals Limited (ASX:RCE), a leading developer of synthetic anti-infectives, today announced it has received Human Research Ethics Committee (HREC) approval for a significant protocol amendment. This approval advances the Company’s clinical trial of RECCE® 327 Topical Gel (R327G) in Australia to a pivotal Phase 3 study for Diabetic Foot Ulcer Infections (DFI). Recce is developing a new class of synthetic anti-infectives designed to address the urgent global health problems of antibiotic-resistant superbugs. This pivotal Phase 3 trial is designed to generate the safety and efficacy data required to support regulatory approval applications.
The HREC-approved amendment significantly broadens patient eligibility, now including individuals with Moderate DFI in addition to previously approved Mild DFI cases. This expansion is crucial as mild and moderate DFI presentations collectively account for approximately 80% of all diabetic foot infection cases, thereby greatly increasing the potential recruitment pool for R327G. Given R327G’s favourable safety profile, the study now also includes infected ulcers below the knee, enabling an additional primary endpoint analysis at the individual ulcer level, which increases the study’s statistical power and enhances its probability of success.
With these expanded parameters, Recce now operates two parallel pivotal Phase 3 programs in Australia and Indonesia, both conducted to US FDA regulatory standards. These trials form the cornerstone of the Company’s global DFI registration strategy, targeting approvals across Australia, the United States, MENA, and ASEAN markets. The Australian pivotal Phase 3 trial has currently enrolled 18 of an anticipated 200 patients, with an interim analysis planned upon 50% patient completion. Full enrolment across both studies is expected by the end of 2027. This advancement also supports the Company’s recently signed non-binding term sheet for exclusive licensing of R327G across 12 MENA countries, with the company’s CEO highlighting the acceleration of global registration and broadening market opportunity.
