Recce Pharmaceuticals Ltd ( ASX:RCE , OTC:RECEF ) has reached a key milestone in its pivotal Phase 3 diabetic foot infection trial, with an independent Data Monitoring Committee (DMC) set to review unblinded efficacy and safety data after a review of blinded results indicated encouraging clinical outcomes and a positive safety profile.
A dataset covering 75 patients has been formally submitted to the DMC, which will separate patients who received RECCE® 327 Gel (R327G) from those given placebo and assess outcomes by treatment group.
The committee is expected to provide recommendations following a meeting that could take place as soon as mid-November 2026, while patient recruitment and dosing will continue during the review.
The Phase 3 study in Indonesia is evaluating R327G as a treatment for diabetic foot infections and currently has 90 patients enrolled, with recruitment running at around 4.5 patients per week. RCE(7)
Blinded review shows encouraging outcomes
An independent review involving Australian and international infectious disease specialists, clinical investigators and biostatistical experts found a high proportion of patients experienced either resolution or improvement of infection across the study population.
Blinded safety data also continued to indicate that R327G was safe and well tolerated, although Recce, investigators and patients remain unaware of individual treatment allocations to preserve the integrity of the trial.
The DMC review will provide the first independent assessment of outcomes according to whether patients received R327G or placebo.
Its recommendations could include progressing towards regulatory submission and potential product registration if supported by the data, continuing the study unchanged, modifying the protocol or, if warranted, pausing or stopping the trial.
Recce chief executive officer James Graham said the review represented an important milestone for the company's Phase 3 diabetic foot infection program.
"While Recce remains blinded to treatment allocation, the overall efficacy and safety profile observed to date is encouraging," Graham said.
R327G targets diabetic foot infections
The pivotal double-blind, placebo-controlled study is assessing the efficacy and safety of topical R327G in patients with diabetic foot infections, a serious complication of diabetes that can be difficult to treat and is associated with substantial unmet medical need.
The independent DMC forms part of the trial's Good Clinical Practice oversight and is responsible for periodically assessing accumulating efficacy and safety data and advising on the study's ongoing conduct.
