Recce Pharmaceuticals has secured ethics approval to upgrade and broaden its pivotal Phase 3 trial of RECCE® 327 Topical Gel for diabetic foot infections in Australia, accelerating recruitment and reinforcing its global registration ambitions.
- HREC approval advances Australian Phase 3 trial to pivotal status
- Patient eligibility expanded to include moderate diabetic foot infections
- Inclusion of infected ulcers below the knee increases study power
- Parallel Phase 3 trials in Australia and Indonesia underpin global strategy
- Supports recent non-binding licensing deal for MENA commercialisation
Ethics Approval Elevates Australian Trial to Pivotal Phase 3
Recce Pharmaceuticals (ASX:RCE) has received Human Research Ethics Committee (HREC) approval to amend the protocol of its ongoing clinical trial of RECCE® 327 Topical Gel (R327G) in Australia, effectively upgrading the study to a pivotal Phase 3 trial for diabetic foot infections (DFI). This transition marks a critical step toward regulatory registration, with the trial designed to meet both Australian Therapeutic Goods Administration (TGA) and US Food and Drug Administration (FDA) standards.
Broadened Patient Eligibility Targets Majority of DFI Cases
The amendment notably expands patient inclusion criteria to encompass moderate DFI cases alongside mild infections, collectively representing around 80% of DFI presentations. This broader enrolment scope is expected to accelerate recruitment, with the trial aiming to enrol 200 patients by the end of 2027. Additionally, the study now includes infected ulcers below the knee, allowing for an extra primary endpoint analysis at the individual ulcer level. This enhancement increases the statistical power of the trial and potentially improves the chances of demonstrating clinical success.
Strong Early Data and Safety Profile Underpin Confidence
Recce’s confidence in advancing the trial is supported by previously completed Phase 2 data, which showed a 93% primary efficacy endpoint at Day 14 and an 86% clinical response by Day 7 in patients with acute bacterial skin and skin structure infections (ABSSSI) and DFI, with no serious adverse events reported. To date, 18 patients have been treated under the Phase 3 protocol, with an interim analysis planned once half the cohort completes treatment.
Global Registration Strategy Anchored by Dual Phase 3 Trials
This pivotal trial in Australia runs alongside a parallel Phase 3 program in Indonesia, together forming the backbone of Recce’s global regulatory strategy targeting approvals across Australia, the United States, the Middle East and North Africa (MENA), and ASEAN markets. The Indonesian trial recently passed a key regulatory inspection and continues patient dosing, supporting a robust pathway to market in regions with high diabetes prevalence.
Commercial Potential Amplified by Licensing Agreement
The clinical advancement also underpins Recce’s recently signed non-binding licensing term sheet with a leading Middle Eastern pharmaceutical company for exclusive commercialisation of R327G across 12 MENA countries. This deal aims to capitalise on the significant unmet medical need in regions burdened by high rates of diabetes-related amputations and antimicrobial resistance driving treatment failures. The licensing arrangement includes milestone and royalty payments, signaling growing commercial interest in Recce’s synthetic anti-infective platform.
Bottom Line?
Recce’s expanded Phase 3 trial design and accelerated recruitment timeline sharpen its global registration trajectory, but clinical and regulatory milestones over the next 18 months will be critical to validating its commercial promise.
Questions in the middle?
- Will interim Phase 3 data confirm the strong efficacy signals seen in Phase 2?
- How quickly can Recce progress regulatory submissions across multiple jurisdictions?
- What are the prospects for converting the non-binding MENA licensing term sheet into a definitive agreement?