Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) says a routine regulatory inspection of one of its Indonesian Phase 3 clinical trial sites has cleared the way for the study to continue, marking an important step forward in its push toward registration for diabetic foot infections.
The inspection, carried out by Indonesia’s National Agency of Drug and Food Control (Badan POM), reviewed trial conduct, site processes, data integrity and compliance with Good Clinical Practice standards at a site involved in the company’s Phase 3 R327-G301 study.
Recce said the regulator did not request any changes to the ongoing trial and reported no findings that would prevent the study from continuing.
The outcome is significant for the company because it reduces regulatory risk around the registrational study and reinforces the integrity of its clinical operations in Indonesia. For Recce, that keeps a clear line of sight to a potential approval pathway in what it sees as an important commercial entry point into the region.
“We are pleased with the outcome of BPOM's inspection, which reinforces the high standards of our clinical program maintained by our teams and partners working throughout Indonesia. This result provides further confidence in the integrity of our data collection and the robustness of our development pathway as we progress towards potential regulatory approval. The company looks forward to continuing its engagement with BPOM and advancing its clinical programs in the region,” Recce CEO, James Graham, said.
Trial remains on track toward interim analysis
Patient dosing is continuing across five trial sites in Indonesia, with interim data analysis planned once 155 patients have completed the study.
Recce has flagged Indonesia as a near-term commercial opportunity, with regulatory approval anticipated in calendar 2026. Success there could also help support expansion into other ASEAN markets.
The company is developing its synthetic anti-infectives as a potential treatment option for diabetic foot infections, an area of significant unmet need in Indonesia given the country’s large diabetes population.