Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) earlier this week began patient dosing in its Phase II clinical trial of R327 for the treatment of diabetic foot infections in Indonesia. James Graham, Recce's CEO, joined Proactive to explain.
Highlights
- Recce Pharmaceuticals has begun dosing patients with R327 in Indonesia for diabetic foot ulcer infections.
- Diabetes prevalence in Indonesia is around 11%, equating to 21.00 million people.
- Patients with diabetes face about a 60% chance of developing a diabetic ulcer and nearly 100% chance of infection.
- Five clinical sites are now active, with a target enrollment of 310 patients.
- Interim analysis will occur at 155 patients, expected in Q1 2026.
- The Indonesian FDA (BPOM) has indicated readiness for expedited regulatory review.
- Approval in Indonesia could support broader approvals across ASEAN, the Middle East and beyond.
- Commercial discussions with regional pharmaceutical partners are already underway.
The study will involve up to 310 patients across five clinical sites. An interim analysis is planned after 155 patients are enrolled. This analysis is expected to take place in the first quarter of 2026 and will provide statistically significant data that could support regulatory approval.
Prevalance in Indonesia
Recce told investors that diabetes affects around 11.00% of the Indonesian population, or about 21.00 million people. The company highlighted that people with diabetes have a 60% chance of developing a diabetic ulcer and almost all of those ulcers become infected.
James Graham said he attended the first dosing of a patient in Jakarta. He described the enthusiasm of clinicians across the participating hospitals and noted that he personally observed a patient with a diabetic foot ulcer being administered the company’s compound.The company said discussions with the Indonesian FDA, known as BPOM, reinforced the importance of the trial. BPOM indicated it is prepared to provide expedited regulatory review based on the interim data. Recce noted that an accelerated approval pathway is possible.
Commercial Plans Beyond Indonesia
Regulatory approval in Indonesia would provide a gateway to broader approvals across ASEAN member countries, as well as the Middle East and other regions. It added that commercial discussions with pharmaceutical companies in these areas are already underway.
Recce told investors that the Indonesian market is significant due to the scale of diabetes prevalence. It added that approval in Indonesia could provide the foundation for expansion of R327 into additional jurisdictions.
The company said the trial represents both a major step in its development plans and a potential contribution to the fight against antimicrobial resistance in diabetic foot infections.