Recce Pharmaceuticals (ASX:RCE) has received approval from the Human Research Ethics Committee to advance its Australian study of RECCE 327 Topical Gel to a pivotal Phase 3 trial for diabetic foot infections (DFI), a move the company says accelerates its global registration strategy.
The approved protocol amendment expands eligibility to include both Moderate and Mild DFI, significantly broadening the pool of recruitable patients. These cases account for roughly 80 per cent of presentations. The study will also include infected ulcers below the knee, in addition to infected foot ulcers, enabling an additional primary endpoint analysis at the individual-ulcer level to increase study power.
Diabetic foot infection is a major cause of hospitalisation and lower limb amputation for people living with diabetes, and Recce positions R327G as a topical anti-infective option intended to address increasing antimicrobial resistance and unmet clinical need.
The company said the trial is being run to TGA and US FDA regulatory standards and currently has 18 patients completed out of an anticipated 200-patient cohort.
An interim analysis is planned when 50 per cent of patients have completed treatment, and full enrolment is expected by the end of 2027. Recce notes previously completed Phase 2 data demonstrating a 93 per cent primary efficacy endpoint at Day 14 and an 86 per cent clinical response by Day 7 in ABSSSI and DFI patients, with no serious adverse events reported.
Recce now has two parallel registrational Phase 3 programs operating in Australia and Indonesia, forming the cornerstone of its global DFI registration plan targeting approvals across Australia, the United States, MENA, and ASEAN. The expanded Australian program also supports the company’s recently executed non-binding term sheet for exclusive commercialisation of R327G across 12 MENA countries.
Recce Chief Executive Officer James Graham said, “Receiving HREC approval to expand and accelerate our Australian Phase 3 program is a significant milestone for Recce and for 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. The expansion to Moderate DFI materially broadens the patient population and the market we are targeting. This is a program that is advancing rapidly, and the commercial opportunity is growing with it."
