Recce Pharmaceuticals says a review of blinded Phase 3 data for its RECCE 327 Gel showed strong efficacy and a positive safety profile. An independent committee is expected to assess unblinded data from 75 patients as soon as mid-November, while recruitment continues.
- Strong efficacy indicated in blinded review of 75 patients
- Independent DMC to assess treatment-group data in mid-November
- 90 patients enrolled in the Indonesian Phase 3 trial
- Recruitment continues at 4.5 patients per week
- Formal recommendations could range from continuation to regulatory progression or a trial halt
Independent committee moves to unblind Phase 3 data
Recce Pharmaceuticals Ltd (ASX:RCE) is approaching a pivotal checkpoint for its RECCE 327 Gel, with an independent Data Monitoring Committee preparing to review unblinded efficacy and safety data from the company’s Phase 3 diabetic foot infection trial in Indonesia.
The company said a preliminary review of blinded data from 75 patients indicated strong efficacy across the study population, with a high proportion of patients experiencing either resolution or improvement of infection. The same review found that R327G continued to show a positive safety and tolerability profile, although Recce has not disclosed treatment-arm results or numerical efficacy measures.
The DMC will be the first party to see which patients received R327G and which received placebo gel. Recce, the investigators and the patients will remain blinded during the review, preserving the trial’s design while allowing the committee to assess outcomes by treatment group. Its meeting is expected to take place as soon as mid-November 2026.
Recruitment continues as the trial reaches 90 patients
The double-blind, placebo-controlled study has now enrolled 90 patients, with recruitment running at 4.5 patients per week. The trial will continue recruiting and dosing while the DMC conducts its assessment, so the review does not yet represent the completion of the study.
The Indonesian program sits alongside Recce’s wider Phase 3 development work, including the Australian active comparator arm approved earlier for head-to-head comparison against physician-selected antibiotics. That broader development strategy is relevant because the current filing provides an encouraging signal, but not yet the treatment-group evidence normally needed to support a regulatory submission.
DMC recommendations could reshape the next stage
After its meeting, the committee may recommend progressing towards regulatory submission if the unblinded data support that path, continuing the trial unchanged, amending elements such as sample size or dosing, or pausing or halting the study because of safety concerns or clear futility. Recce said it will provide a further market update after receiving and evaluating the formal recommendation.
That range matters. The company’s blinded assessment is directionally positive, but the material question remains whether the apparent benefit is concentrated in the R327G group and whether the safety profile holds once treatment allocations are revealed. The mid-November review should provide the next meaningful test of the program’s claims.
Bottom Line?
The blinded results are encouraging, but the investment-sensitive evidence remains locked inside the DMC review: treatment-arm outcomes and the committee’s recommendation are the next catalysts.
Questions in the middle?
- Will the unblinded data show a clear efficacy advantage for R327G over placebo?
- Will the DMC recommend continuing the current design, changing the protocol, or moving towards regulatory submission?
- How many patients and what final study design will be required before Recce can support a registration application?