Recce Pharmaceuticals (ASX:RCE) has received approval from the Indonesian Drug and Food Regulatory Authority to initiate its registrational Phase 3 clinical trial, which will assess RECCE 327 as a topical gel for treating diabetic foot infections.
The company said the significant milestone follows the recent approval of the human ethics committee to commence patient dosing. It said it remains on track to begin the registrational Phase 3 clinical trial this quarter.
Commenting on the approval, the Indonesian Food and Drug Authority Chairperson, Dr Taruna Ikrar, said, "The approval of Recce Pharmaceuticals' Phase 3 clinical trial is an important advancement in expanding treatment options for diabetic foot infections in Indonesia. BPOM is committed to fostering the timely development of innovative therapies to address urgent health challenges. This collaboration reflects Indonesia’s mission to enhance healthcare outcomes for its population, and we are eager to see the trial’s impact on patients requiring effective, novel anti-infective treatments.”
With over 19.5 million adults living with diabetes in Indonesia, the need for innovative therapies to address diabetes-related infections, such as foot infections, urinary tract infections, and surgical site infections, is urgent.
It will be one of the most significant DFI studies of diabetic foot infections globally and the first across Indonesia.
The trial will be conducted as a double-blinded, placebo-controlled study evaluating R327G for treating diabetic foot infections and aims to enrol up to 300 patients. The trial will run for approximately 12 months, with an expected read-out in late 2025 and potentially regulatory approval and commercial launch in the first half of calendar year 2026.
Recce Pharmaceuticals CEO James Graham said, “The approval from the Indonesian National Drug and Food Authority to initiate this pivotal Phase 3 trial in Recce’s clinical development is a significant achievement, bringing Recce closer to commercialisation and profitability. We also acknowledge the support of Investment NSW, Austrade, and the Australian Embassy team in Jakarta who played an important role in helping with the approval process. We look forward to evaluating R327G in our first Phase 3 trial.”