Independent DMC to review Phase 3 diabetic foot infection data as blinded results show strong efficacy
In its latest update, Recce Pharmaceuticals advised that a data set of 75 patients from its Phase 3 diabetic foot infection trial in Indonesia has been formally submitted to the independent Data Monitoring Committee (DMC). The DMC will unblind the data, and its recommendations are expected following a meeting expected to occur as soon as mid-November 2026.
A recent review of the blinded data by Australian and international infectious disease specialists, clinical investigators and biostatistical experts was conducted following completion of patient follow-up. It demonstrated encouraging clinical outcomes across the study population, with a high proportion of patients experiencing either resolution or improvement of infection.
The blinded safety data continue to indicate that RECCE® 327 Gel (R327G) is safe and well tolerated. Recce itself remains blinded to treatment allocation, so the efficacy signal relates to blinded data only and is not a confirmed treatment result.
Patient recruitment and dosing remain ongoing during the DMC review.
James Graham, Chief Executive Officer
“The forthcoming DMC review represents an important milestone in our Phase 3 diabetic foot infection program. While Recce remains blinded to treatment allocation, the overall efficacy and safety profile observed to date is encouraging…”
Key figures
- 75 patients submitted to the DMC
- 90 patients currently enrolled
- 4.5 patients per week existing enrolment rate
- DMC meeting expected as soon as mid-November 2026
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How a Data Monitoring Committee review works
An independent DMC is described in the announcement as an important component of any pivotal study conducted in accordance with Good Clinical Practice (GCP). Its role is to periodically review accumulating clinical trial data, including efficacy and safety outcomes, and provide recommendations regarding the ongoing conduct of the study.
Recce’s Indonesian GCP inspection by Badan POM concluded with no findings, supporting the data integrity of the trial population now being submitted for DMC review.
Why unblinding matters
In a double-blind, placebo-controlled trial, neither patients nor researchers know who receives the active treatment and who receives a placebo gel. Unblinding means the DMC is granted access to the treatment allocations that reveal which patients received R327G versus the placebo gel.
This allows the committee to assess patient outcomes by treatment group and determine appropriate recommendations on the progression of the study. During the ad-hoc review, the Company, clinical investigators and patients will remain fully blinded to protect the scientific integrity of the trial.
The DMC process is built into the clinical trial protocol and is typically part of any pivotal GCP protocol, which makes it a standard step. For investors, it is the independent look at the treatment-versus-placebo comparison in this trial, so the outcome could be a key value inflection point.
Possible DMC recommendations
Following its meeting, the DMC will submit its findings and recommendations to the Company. In accordance with standard clinical protocols, the recommendations may include:
- Advising the Company to progress towards regulatory submission and potential product registration, if supported by the safety and efficacy data
- Continuing the trial unchanged without modifications
- Amending the trial protocol (such as modifying sample sizes, dosing schedules, or patient selection criteria) to optimise patient safety or study validity
- Pausing or halting the trial due to safety concerns or clear futility
Diabetic foot infections and the R327G opportunity
The study is a pivotal, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of RECCE® 327 Gel (R327G) in the treatment of diabetic foot infections (DFI) in Indonesia. Currently, 90 patients are enrolled.
Mr Graham said DFI represents a significant global healthcare challenge and an area of substantial unmet medical need. In his view, R327G is “anticipated to become the standard of care for the treatment of Diabetic Foot Ulcer Infections”, a statement that reflects management’s expectation only.
| Milestone | Detail | Investor significance |
|---|---|---|
| Blinded efficacy review | Experts reported a high proportion of patients with resolution or improvement of infection | Encouraging, but based on blinded data and not a confirmed treatment result |
| Blinded safety profile | Blinded safety data continue to indicate R327G is safe and well tolerated | Consistent with the safety profile reported to date |
| DMC unblinded review | **75 patients** submitted; meeting expected as soon as **mid-November 2026** | First independent treatment-versus-placebo comparison in this trial |
| Ongoing recruitment | **90 patients** enrolled at **4.5 patients per week** | Recruitment and dosing continue during the review |
Regulatory backing and what comes next
The announcement lists the following recognition for Recce’s anti-infective pipeline:
- The World Health Organization (WHO) added R327, R435 and R529 to its list of antibacterial products in clinical development for priority pathogens
- The FDA granted R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, providing Fast Track Designation and 10 years of market exclusivity post approval
- R327 is included on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the sole synthetic polymer and sepsis drug candidate in development
- Recce wholly owns its automated manufacturing, supporting current clinical trials
Recce will provide a market update once it has received and evaluated the DMC’s formal recommendations, in accordance with its continuous disclosure obligations.
Commercial interest is already visible, with a MENA licensing term sheet covering ten markets and up to USD $3.5M in milestones signed ahead of any Phase 3 readout.
The near-term catalyst is the DMC meeting, expected as soon as mid-November 2026.
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