Key Highlights

  • An independent Data Monitoring Committee will review unblinded Phase 3 data on RECCE 327 Gel in diabetic foot infections.
  • Data from 75 patients has been submitted, and 90 patients are enrolled at about 4.5 patients per week.
  • The committee's recommendations are expected as soon as mid-November 2026.
  • Patient recruitment and dosing continue during the review.

Recce Pharmaceuticals Ltd (ASX:RCE) announced on 20 October 2026 that a data set of 75 patients from its Phase 3 trial of RECCE 327 Gel (R327G) has been formally submitted to an independent Data Monitoring Committee (DMC). The committee will unblind the data and prepare recommendations, with its meeting expected as soon as mid-November 2026.

The Phase 3 trial

The study is a pivotal, double-blind, placebo-controlled Phase 3 trial in Indonesia evaluating the efficacy and safety of R327G in diabetic foot infections. Currently, 90 patients are enrolled at an enrolment rate of about 4.5 patients per week. Patient recruitment and dosing remain ongoing while the committee conducts its review.

Blinded data review

A review of blinded data by clinical experts and a statistician, completed after patient follow-up, was described as showing encouraging clinical outcomes across the study population, with a high proportion of patients experiencing resolution or improvement of infection. The blinded safety data continue to indicate that R327G is safe and well tolerated. These observations are based on blinded data, meaning the review did not compare patients who received the gel with those who received placebo.

Role of the committee

The DMC's role is to periodically review accumulating trial data, including efficacy and safety outcomes, and to recommend how the study should proceed, which is a standard feature of pivotal trials conducted under Good Clinical Practice. The committee will be given access to treatment allocations so that it can compare outcomes between patients who received R327G and those who received placebo. The company, clinical investigators and patients will remain fully blinded throughout to protect the integrity of the trial.

Possible recommendations

The release lists the recommendations the committee may make. They include advising the company to progress towards regulatory submission and potential product registration if the safety and efficacy data support it, continuing the trial unchanged, amending the trial protocol, for example by modifying sample sizes, dosing schedules or patient selection, or pausing or halting the trial because of safety concerns or clear futility. The company has not indicated which outcome it expects.

Disclosure commitment

Recce will issue a market update once it has received and evaluated the committee's formal recommendations, in line with its continuous disclosure obligations. The company describes diabetic foot infection as an area of unmet medical need, and its chief executive says the forthcoming review is an important milestone for the program.

Review of the blinded data

The blinded review was conducted by Australian and international infectious disease specialists, clinical investigators and biostatistical experts after completion of patient follow-up. Because it relied on blinded data, it did not compare patients who received R327G with those who received placebo.

About the company

Recce describes itself as a developer of a new class of synthetic anti-infectives and is listed on the ASX and the Frankfurt Stock Exchange. It characterises diabetic foot infection as a global healthcare challenge and an area of substantial unmet medical need.

Summary of the update

The announcement records a 75-patient data submission to an independent committee, a review expected from mid-November, four possible recommendation outcomes and continuing enrolment among 90 enrolled patients.