Recce Pharmaceuticals gains key approval to advance diabetic foot infection trial to pivotal Phase 3 Proactive uses images sourced from Shutterstock
Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has secured Human Research Ethics Committee (HREC) approval to advance its Australian clinical trial of RECCE® 327 Topical Gel (R327G) for diabetic foot infections (DFI) to a pivotal Phase 3 study, marking a key step in the company’s global registration strategy.
The approval covers a protocol amendment that broadens the trial beyond mild DFI patients to include moderate infections, materially expanding the eligible patient pool. Mild and moderate cases together account for around 80% of DFI presentations.
The trial will also now include infected ulcers below the knee, in addition to infected foot ulcers, allowing Recce to conduct an additional primary endpoint analysis at the individual ulcer level.
What the approval means
The HREC approval elevates the Australian study to pivotal Phase 3 status, meaning it is designed to generate safety and efficacy data that may support future regulatory approval applications.
The trial is being conducted to Therapeutic Goods Administration (TGA) and US Food and Drug Administration (FDA) regulatory standards.
The company now has two registrational or pivotal Phase 3 DFI trials operating in parallel in Australia and Indonesia, forming the basis of its global registration strategy for R327G across Australia, the United States, MENA and ASEAN markets.
Broader recruitment pool
The amended protocol is expected to accelerate patient recruitment by allowing moderate DFI patients to enrol alongside mild cases.
The Australian pivotal Phase 3 trial has so far completed treatment for 18 patients out of an anticipated 200-patient study. Recce expects full enrolment by the end of 2027.
An interim analysis is planned once 50% of patients have completed treatment.
The primary endpoint will assess clinical response using the Lipsky Scale, while secondary endpoints will evaluate total wound score and the safety profile of R327G.
Building on Phase 2 data
The approval follows Recce’s previously completed Phase 2 ABSSSI/DFI clinical trial, which achieved a 93% primary efficacy endpoint at Day 14 and an 86% clinical response by Day 7, with no serious adverse events reported.
Recce chief executive officer James Graham said the approval was a significant milestone for the company and for patients with diabetic foot infections.
“With 2 concurrent Phase 3 programs now operating in Australia and Indonesia, we are moving with pace toward global registration,” Graham said.
“The expansion to moderate DFI materially broadens the patient population and the market we are targeting.”
Commercial pathway
The advancement of the DFI program also supports Recce’s recently signed non-binding term sheet with a leading Middle Eastern pharmaceutical company for exclusive commercialisation of R327G across 12 MENA countries.
DFI remains a major cause of hospitalisation and lower limb amputation among people living with diabetes. Recce said antimicrobial resistance was contributing to treatment failure, reinforcing the need for new topical anti-infective therapies.
R327G is part of Recce’s broader synthetic anti-infective pipeline, which is being developed to address serious bacterial and viral infections, including antibiotic-resistant pathogens.