Recce Pharmaceuticals Expands Phase 3 Trial with Active Comparator in Diabetic Foot Infections
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11:02am on Wednesday 19th of August, 2026 AEST ~11am, 19th Aug, 26
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Recce Pharmaceuticals has secured ethics approval to add an active-controlled arm to its pivotal Phase 3 trial of RECCE® 327 Topical Gel for diabetic foot infections in Australia, enabling head-to-head comparison against existing antibiotics.
- HREC approves active-controlled, non-inferiority arm in Phase 3 DFI trial
- 208 patients to be randomised between R327G and physician-selected antibiotics
- Multiple efficacy assessments per participant to deepen clinical data
- Wound imaging introduced for objective infection measurement
- Supports global regulatory strategy targeting Australia, US, MENA, ASEAN
Active-Controlled Arm Adds Competitive Edge to Phase 3 Trial
Recce Pharmaceuticals (ASX:RCE) has taken a significant step in its pivotal Phase 3 clinical trial of RECCE® 327 Topical Gel (R327G) for diabetic foot infections (DFI) by obtaining Human Research Ethics Committee (HREC) approval for a protocol amendment in Australia. This amendment introduces a randomised, active-controlled, non-inferiority study arm enrolling 208 patients, who will be randomised between R327G and one of four physician-selected comparator antibiotics. This head-to-head design aims to generate robust comparative data against existing antibiotic treatments, which currently lack a definitive standard of care in DFIs.
Expanding Data Depth with Multiple Assessments and Wound Imaging
Beyond the new study arm, the amended protocol allows participants randomised to R327G to receive treatment for multiple qualifying DFIs they experience during the trial. This approach is designed to increase the volume and depth of efficacy data, capturing multiple clinical outcomes per participant. Additionally, the trial now incorporates wound imaging using calibrated digital photography, providing standardised and objective measurements of infection sites. This imaging adds a valuable layer of data to complement investigator assessments and is expected to strengthen regulatory submissions across multiple jurisdictions.
Strategic Global Development and Regulatory Positioning
This Australian trial amendment complements Recce’s ongoing pivotal Phase 3 program in Indonesia and aligns with the company’s broader global regulatory strategy targeting approvals in Australia, the United States, Middle East and North Africa (MENA), and ASEAN regions. Patient dosing and recruitment continue under the existing protocol, with an interim analysis planned after 104 participants complete treatment or withdraw. Treatment selection reflects real-world clinical practice, with physicians choosing antibiotics based on pathogen profiles, infection severity, and patient-specific factors such as prior antibiotic exposure and allergy history.
CEO Highlights Potential to Set New Standard of Care
Recce Pharmaceuticals CEO James Graham emphasised the significance of the amendment, stating, "This protocol amendment reflects the significant advancements being made in our Phase 3 Clinical Programs, with continued engagement from trial sites and clinicians. We look forward to patient dosing continuing and generating data for R327G against standard of care antibiotics. R327G has the potential to become the first standard of care used by physicians for the treatment of DFIs."
Bottom Line?
The addition of an active-controlled arm and enhanced data collection methods positions Recce’s R327G as a serious contender to redefine diabetic foot infection treatment standards, with a critical interim readout on the horizon.
Questions in the middle?
- Will the interim analysis confirm non-inferiority of R327G against established antibiotics?
- How will the introduction of wound imaging influence regulatory acceptance and clinical adoption?
- What impact will comparative data have on Recce’s licensing and commercialisation prospects in key markets?
