Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q), a company developing a new class of Synthetic Anti-infectives designed to address antibiotic-resistant superbugs, has announced the commencement of patient dosing in its Phase 3 clinical trial for Diabetic Foot Infections (DFI) in Indonesia. Five clinical study sites have been activated, marking a significant step forward in the trial. The study aims to evaluate RECCE327 Topical Gel (R327G) as a potential treatment for DFIs, targeting a patient enrolment of up to 310 individuals randomised to receive either R327G or a placebo.
The trial’s primary objective is to assess the clinical response of the DFI according to the Lipsky Scale, a method recognised by the FDA for evaluating DFI treatment outcomes. Secondary endpoints include a DFI total wound score and monitoring the safety of R327G, including clinical observations and any adverse events. The company anticipates a highly statistically significant positive endpoint after dosing approximately 155 patients, based on the approved statistical plan.
An interim analysis, conducted by an independent data management committee, is expected in Q1 2026. Upon receiving a positive result, Recce Pharmaceuticals intends to pursue accelerated approval with a potential commercial launch in 2026. The Indonesian Drug and Food Regulatory Authority (Badan POM or BPOM) has granted the study Expedited Regulatory Review status.
Indonesia represents a significant market opportunity for DFI treatments, with an estimated 20.9 million adults living with diabetes, representing approximately 11.3% of the nation’s adult population. The commencement of this Phase 3 trial follows approvals from Indonesia’s Food and Drug Authority (Badan POM) and the Human Research Ethics Committee (HREC). The trial is also supported by both the Indonesian and Australian governments, along with local Indonesian biomedical collaborator PT Etana.
