Recce Pharmaceuticals (ASX:RCE) has cleared a key regulatory hurdle in Indonesia, with the company confirming that a routine inspection of its Phase 3 clinical trial site for diabetic foot infections has been completed without issue, reinforcing confidence in both the study’s integrity and its broader pathway to approval.
The inspection, conducted by the Indonesian National Agency of Drug and Food Control, known as BPOM, formed part of standard oversight and involved a detailed review of trial conduct, site processes, data integrity and compliance with Good Clinical Practice standards. According to the company, no findings were identified that would prevent the study from continuing, effectively removing a layer of regulatory uncertainty at a critical stage of development.
The trial, known as R327 G301, is progressing across five sites in Indonesia, with patient dosing ongoing and an interim analysis planned once 155 patients have been completed. The company positions the clean inspection outcome as a de-risking milestone for a registrational study, supporting a pathway to approval in Indonesia before potential expansion into other ASEAN markets.
Chief executive James Graham framed the result as validation of the company’s clinical execution and underlying data quality, stating, “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.”
The Indonesian market represents a significant near-term opportunity for Recce, with regulatory approval anticipated in calendar year 2026. The commercial rationale is anchored in the scale of diabetes in the country, where more than 20 million adults are affected, placing Indonesia among the highest prevalence markets globally. This creates a substantial addressable population for diabetic foot infections and positions the company at the entry point to a broader Asia Pacific market estimated at around US$1.5 billion.
Recce’s broader strategy is built around its synthetic anti-infective platform, including RECCE 327, which is being developed as both an intravenous and topical therapy targeting serious infections, including those involving antibiotic-resistant bacteria.