Recce Pharmaceuticals (ASX:RCE) has reached a regulatory milestone following the completion of a routine inspection by the Indonesian National Agency of Drug and Food Control.
The comprehensive audit of a Phase 3 clinical trial site for the treatment of diabetic foot infections concluded with no requested changes to the study's conduct, affirming the integrity of the clinical operations and strict adherence to international Good Clinical Practice standards.
The positive outcome serves as a de-risking event for the registrational Phase 3 trial (R327-G301).
By validating the site’s processes and data management, BPOM has cleared the path for Recce to continue patient dosing across its five Indonesian sites without interruption.
The progress is essential for the company's broader strategy to secure regulatory approval and commercialisation within Indonesia—a nation where diabetes affects over 20.9 million adults—before expanding into the wider ASEAN market.
"This result reinforces the high standards of our clinical programme and provides further confidence in our development pathway," stated James Graham, CEO of Recce Pharmaceuticals.
The trial remains on track, with an interim data analysis scheduled once 155 patients have completed the study.
At the time of reporting, Recce Pharmaceuticals’ share price was $0.54.