HREC approves active-controlled study arm for Recce’s pivotal Phase 3 DFI trial
Recce Pharmaceuticals (ASX:RCE) has secured approval from Australia’s Human Research Ethics Committee (HREC) for a protocol amendment to its pivotal Phase 3 DFI trial of RECCE® 327 Topical Gel (R327G) in Diabetic Foot Infections (DFI).
Announced on 19 August 2026, the amendment adds a new randomised, active-controlled, non-inferiority study arm. It randomises 208 patients between R327G and one of four physician-selected comparator antibiotics.
The strategic prize is significant. According to the Company, there is no specific existing standard of care for DFIs, meaning a successful outcome could position R327G as the first standard of care treatment for the indication.
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What the protocol amendment changes
The amendment introduces a head-to-head comparative arm into an already-running Phase 3 trial. Patient dosing, recruitment and treatment continue under the existing protocol ahead of implementation of the newly approved changes.
The addition is designed to generate comparative clinical data for R327G against established antibiotic options used in DFI management. Key features include:
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208 participants randomised between R327G and a physician-selected antibiotic
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Four physician-selectable comparator antibiotics
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A planned interim analysis conducted by the Independent Data Monitoring Committee after 104 total participants have been enrolled, randomised, treated and followed to the end of treatment or withdrawn prematurely
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Amended inclusion criteria allowing R327G participants to be treated for each qualifying DFI they experience, enabling multiple efficacy assessments per participant
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New wound imaging using calibrated digital photography to capture standardised, objective wound measurements
The combination of comparative data and objective imaging is intended to strengthen the data package supporting global regulatory submissions.
| Amendment Feature | Detail | Why It Matters to Investors |
|---|---|---|
| New active-controlled arm | 208 patients randomised vs comparator antibiotics | Generates comparative efficacy data against established treatments |
| Interim analysis | Triggered after 104 participants | Provides an early read on trial progress |
| Multiple DFI assessments per patient | Each qualifying DFI treated during study | Increases the volume and depth of efficacy data |
| Wound imaging | Calibrated digital photography for objective measurement | Strengthens the global regulatory package |
Why diabetic foot infections matter
Diabetic foot infections are a serious complication for people living with diabetes, and treatment can be complex.
Selecting the right treatment is far from straightforward. According to the Company, therapy is guided by the suspected or known causative pathogen and its antibiotic susceptibility, infection severity, and patient-specific factors such as prior antibiotic exposure, allergy history and the risk of methicillin-resistant Staphylococcus aureus (MRSA).
Therapy is refined where appropriate according to culture and sensitivity results, adding further clinical variability.
Critically, there is no specific existing standard of care for DFIs. This gap is the market Recce aims to address. A first-in-class standard of care in an underserved indication represents a notable commercial opportunity for the Company if the trial succeeds.
Fitting into Recce’s global regulatory strategy
The Australian arm reinforces the Company’s ongoing pivotal Phase 3 DFI program in Indonesia and stands as a core pillar of Recce’s global development and regulatory strategy. That strategy spans four regions:
The Australian arm reinforces a program that only recently achieved pivotal Phase 3 registrational status, with the earlier HREC approval expanding eligibility to Mild and Moderate DFI patients and targeting approximately 80% of all DFI presentations to accelerate enrolment.
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Australia
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United States
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MENA
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ASEAN
The randomised, active-controlled, non-inferiority design is intended to produce the comparative evidence relevant across these markets.
R327 carries a strong regulatory foundation. The FDA granted R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Incentives Now (GAIN) Act, providing Fast Track Designation and 10 years of market exclusivity post approval. It is also listed by the World Health Organization (WHO) among antibacterial products in clinical development for priority pathogens, and is included on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the sole synthetic polymer and sepsis drug candidate.
A MENA licensing term sheet has already been executed ahead of Phase 3 data, covering ten markets with 84 million diabetics and proposing up to USD $3.5 million in milestone payments plus a 30% share of the net selling price per treatment.
CEO Commentary
“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,” said James Graham, Chief Executive Officer.
What comes next
Patient dosing continues under the existing trial protocol, with recruitment and treatment progressing ahead of implementation of the newly approved amendment. The planned interim analysis will be triggered once 104 participants have been enrolled, randomised, treated and followed to the end of treatment or withdrawn prematurely.
For investors, the amendment materially strengthens the evidence base being assembled. If the comparative data proves favourable, it could support R327G’s positioning as the first standard of care in DFI across Recce’s targeted global markets, an outcome that would carry meaningful commercial implications in a currently underserved indication.
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