Recce Pharmaceuticals Advances Phase 3 Diabetic Foot Infection Trial to Independent Data Review

Recce Pharmaceuticals has submitted a 75-patient dataset from its pivotal Phase 3 diabetic foot infection trial to an independent Data Monitoring Committee, which will review unblinded efficacy and safety data. The Australian clinical-stage biopharmaceutical company said the committee is expected to meet as soon as mid-November 2026. The details were reported by EIN Presswire.

Recce's Phase 3 Data Review

The blinded 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 continued to indicate that RECCE® 327 Gel was safe and well tolerated, while Recce, investigators and patients remain unaware of individual treatment allocations.

The committee will separate patients who received RECCE® 327 Gel from those given placebo and assess outcomes by treatment group. Its recommendations could include progressing towards regulatory submission and potential product registration, 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.

The Phase 3 study in Indonesia is evaluating RECCE® 327 Gel as a treatment for diabetic foot infections and currently has 90 patients enrolled, with recruitment running at around 4.5 patients per week. Patient recruitment and dosing will continue during the review.

Recce's Trial Scale and Funding

According to akta.pro company records, Recce Pharmaceuticals operates two parallel registrational Phase 3 trials in Australia and Indonesia for RECCE® 327 Topical Gel targeting diabetic foot infections. The company anticipates achieving full enrollment in its Phase 3 clinical trials by the end of 2027 and is targeting global registration across Australia, the United States, MENA and ASEAN following successful Phase 3 trial completion. The same records show a capital raise of approximately AUD 3.1M completed in April 2025 to support ongoing Phase 3 development and corporate operations.

Earlier Recce Milestones

Recce Pharmaceuticals received Australian Human Research Ethics Committee approval in August 2026 to expand its Phase 3 trial for RECCE® 327 Topical Gel by adding a 208-patient active-controlled study arm, according to Proactiveinvestors. In June 2026, the company secured Human Research Ethics Committee approval to advance its Australian clinical trial to a pivotal Phase 3 study, expanding enrollment from mild to include moderate infection cases, Yahoo reported. Recce Pharmaceuticals is advancing R327 through two Phase 3 trials in Indonesia and Australia, with commercialisation targeted for 2027, Proactiveinvestors reported in September 2026.

Recce's Next Steps

The Data Monitoring Committee meeting could take place as soon as mid-November 2026, with recommendations to follow. Recce Pharmaceuticals is targeting commercialisation in 2027.