Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) has received ethics approval from the Human Research Ethics Committee in Indonesia to commence a registrational Phase 3 clinical trial of RECCE® 327 as a topical gel (R327G) for the treatment of diabetic foot infections (DFI). This approval marks a significant step forward in the development of a new therapeutic option for this challenging condition.
The Phase 3 trial is designed as a double-blinded, placebo-controlled study to evaluate the efficacy and safety of R327G in treating DFIs. The trial aims to enroll up to 300 patients, with 200 receiving R327G and 100 receiving a placebo. The study is scheduled to begin in mid-December and will run for approximately 12 months, with an anticipated data readout in late 2025. Regulatory approval and commercial launch are expected in the first half of 2026.
Trial Design and Objectives
The primary objective of the trial is to assess the efficacy of R327G in promoting the healing of diabetic foot ulcers compared to placebo. Secondary endpoints will include evaluating the safety profile of R327G, assessing the time to complete wound closure, and measuring the reduction in infection-related complications. The trial will be conducted at PT Siloam International Hospitals, a large private hospital network in Indonesia.
Addressing a Critical Unmet Need
Diabetic foot infections represent a significant clinical challenge, with an estimated 34% of people with diabetes developing a foot ulcer in their lifetime. Approximately 50% of these ulcers become infected, potentially leading to severe complications such as sepsis, gangrene, amputation, and even death. The DFI treatment market is estimated to be worth approximately US$5.2 billion. Indonesia, where diabetes affects 11% of the population annually, represents a market opportunity of around US$189 million. Broader Asia Pacific market is worth ~US$1.0 billion per year.
Support and Collaboration
The trial is supported by key Indonesian stakeholders, including the Indonesian Ministry of Health, Badan POM, PT Etana Biotechnologies, and the Australian Government. This collaborative effort is expected to accelerate the path to commercialization for R327G. Recce anticipates spending around US$2 million on the study, which will be partially offset by the Australian government’s 43.5% R&D rebate scheme.
Potential for Broader ASEAN Approval
Successful completion of this trial could enable Recce to pursue regulatory approval for R327G across the broader ASEAN region, including Malaysia, the Philippines, Singapore, and Thailand. This would address a critical unmet need for new therapeutics in countries facing increasing rates of antimicrobial resistance and infectious diseases.
Positive Preclinical and Clinical Data
This Phase 3 trial follows promising results from an Acute Bacterial Skin and Skin Structure Infections (ABSSSI) study in Australia, where R327G demonstrated a 100% patient response rate, with all infections cured or improved.
According to Recce Pharmaceuticals CEO James Graham, this ethics approval is a "landmark milestone" in the company's clinical program development. He expressed gratitude for the support from Indonesian partners and emphasized the potential of this therapy to address the needs of patients in Indonesia and the broader ASEAN region.
