Recce Pharmaceuticals (ASX: RCE) has received Human Research Ethics Committee approval to expand and advance its Australian trial of RECCE 327 topical gel to a Phase 3 study for diabetic foot infections.
The approval adds moderate diabetic foot infection patients to the trial protocol, significantly broadening the eligible recruitment pool for the anti-infective treatment.
Recce will also be able to include infected ulcers below the knee in addition to infected foot ulcers, increasing the number of assessable wounds and strengthening the study design.
Diabetic foot infections remain a major cause of hospitalisation and lower extremity amputation among people living with diabetes, while antimicrobial resistance continues to drive treatment failure.
The Australian study now forms part of a dual Phase 3 registration strategy alongside an Indonesian program targeting approvals in Australia, the US, the Middle East and North Africa, and Association of Southeast Asian Nations markets.
Expanded Phase 3 Protocol
Recce confirmed the protocol amendment advances its Australian Phase 2 study of RECCE 327 into a pivotal Phase 3 clinical trial that is designed as a registrational trial to generate the safety and efficacy data required to support future regulatory approval applications.
The trial—which will be conducted to Therapeutic Goods Administration and US Food and Drug Administration standards, with all newly enrolled patients entering under the revised pivotal Phase 3 protocol—has completed treatment in 18 patients from a planned 200-patient study, with interim analysis scheduled once 50% of patients have completed treatment.
Recce reported that mild and moderate DFI cases collectively represent approximately 80% of diabetic foot infection presentations, materially increasing the study’s addressable population.
The trial expansion also allows the inclusion of infected ulcers below the knee, supporting an additional primary endpoint analysis based on individual ulcers.
Primary assessment will measure clinical response using the Lipsky Scale, while secondary endpoints will evaluate total wound score and the safety profile of R327G.
Clinical Data Supports Move
The pivotal expansion builds on earlier Phase 2 acute bacterial skin and skin structure infections and DFI data, which achieved a 93% primary efficacy endpoint at Day 14, along with an 86% clinical response by Day 7, with no serious adverse events reported.
The company is targeting full enrolment by the end of 2027, aided by the expanded eligibility criteria and broader wound inclusion parameters.
Recce chief executive officer James Graham described the approval as a significant step for both the company and patients with diabetic foot infections.
“With two concurrent Phase 3 programs now operating in Australia and Indonesia, we are moving with pace toward global registration,” Mr Graham said.
“This is a program that is advancing rapidly, and the commercial opportunity is growing with it.”