Recce Pharmaceuticals Ltd (ASX:RCE) announced on 20 October 2026 that an independent Data Monitoring Committee (DMC) will review unblinded data from its Phase 3 clinical trial of RECCE® 327 Gel (R327G) for diabetic foot ulcer infections in Indonesia. Recce Pharmaceuticals is a developer of a new class of synthetic anti-infectives. These are designed to address the urgent global health problems of antibiotic-resistant superbugs. A preliminary review of blinded trial data by clinical experts indicated strong efficacy and a very positive safety profile for R327G, which continues to demonstrate excellent safety and tolerability. The DMC’s recommendations are anticipated as soon as mid-November 2026.
The Phase 3 trial is a pivotal, double-blind, placebo-controlled study evaluating R327G’s efficacy and safety in treating diabetic foot infections. Currently, 90 patients are enrolled, with recruitment and dosing ongoing. As a key component of Good Clinical Practice (GCP) compliant clinical studies, the DMC periodically reviews accumulating clinical trial data, including efficacy and safety, to provide recommendations. All parties, except the DMC, remain fully blinded to protect the trial’s scientific integrity.
A recent independent review of the blinded data by specialists demonstrated encouraging clinical outcomes, with a high proportion of patients experiencing either resolution or improvement of infection. Blinded safety data indicates R327G is safe and well tolerated. Following its meeting, the DMC will submit its findings and recommendations. These could include progressing towards regulatory submission, continuing the trial, amending the protocol, or pausing/halting the study. Recce Pharmaceuticals CEO, James Graham, highlighted this review as an “important milestone,” noting the encouraging efficacy and safety profile. The company will provide a market update upon evaluating the DMC’s formal recommendations.
