Recce Pharmaceuticals (ASX:RCE) has taken a significant step forward in its bid to deliver the world’s first dedicated treatment for diabetic foot infections (DFI), with patient dosing now underway in its Phase 3 registrational clinical trial in Indonesia.
The Sydney-based company has activated five trial sites across Indonesia, home to one of the largest DFI patient populations in the world. The study aims to enrol up to 310 patients who will be randomised to receive either Recce’s investigational RECCE 327 Topical Gel (R327G) or placebo.
The trial’s primary goal is to measure clinical response using the FDA-recognised Lipsky Scale, a validated method for assessing DFI outcomes. Secondary endpoints include wound scores and safety assessments. Notably, the design consists of a built-in interim analysis, with results expected in the first quarter of 2026. A positive recommendation from the Independent Data Management Committee could pave the way for accelerated approval and a commercial launch in 2026.
Recce CEO James Graham said the trial highlighted both the urgent clinical need and Indonesia’s unique opportunity. “With R327G positioned as the first potential treatment for DFI, we see ourselves well-positioned to meet the infectious disease challenges among the global rise in diabetes,” he said.
Indonesia represents a significant market. More than 20.9 million adults, 11.3 per cent of the population, live with diabetes, ranking the country fifth in the world. Around 60 per cent of diabetic foot ulcers progress to infection, often leading to amputation, sepsis, or even death. Recce’s Phase 3 program is among the most extensive DFI studies globally, supported by both the Indonesian and Australian governments, and conducted in collaboration with local partner PT Etana.
R327G has already shown encouraging results in Phase 2 studies, demonstrating efficacy in curing infections in patients with acute bacterial skin and skin structure infections, including DFI. The drug was well tolerated with no significant safety concerns, and the Phase 3 protocol was designed to replicate those earlier findings with minimal changes.
Recce’s broader pipeline includes synthetic polymer anti-infectives targeting bacterial and viral pathogens. The World Health Organization has recognised the company’s programs on its list of antibacterial products in development for priority pathogens, underscoring its potential role in addressing antimicrobial resistance.