Can Recce’s New Treatment Overcome Regulatory Hurdles to Address Indonesia’s Diabetic Foot Infection Crisis?

Phase 3 Trial Progress Marks Key Milestone

Recce Pharmaceuticals Ltd (ASX, RCE) has announced the commencement of patient dosing in its Registrational Phase 3 clinical trial for diabetic foot infections (DFI) in Indonesia. This development follows the activation of five clinical sites across the country, a region notable for its large diabetic population. The trial aims to enroll up to 310 patients, randomized to receive either the investigational RECCE 327 Topical Gel (R327G) or placebo, with the primary endpoint focused on clinical response measured by the Lipsky Scale, a recognized standard for DFI treatment outcomes.

Strategic Importance of the Indonesian Market

Indonesia represents a critical market for Recce’s novel therapy, with an estimated 20.9 million adults living with diabetes; approximately 11.3% of the adult population. This prevalence ranks Indonesia fifth globally and underscores the urgent need for effective treatments addressing complications such as diabetic foot infections, which can lead to severe outcomes including amputation and death. The trial’s scale and location position Recce to potentially address one of the largest DFI patient populations worldwide.

Regulatory Pathway and Trial Design

The trial protocol has received approval from Indonesia’s Drug and Food Regulatory Authority (Badan POM) and benefits from Expedited Regulatory Review status. An independent data management committee will conduct an interim analysis after approximately half of the patients have been dosed, with results expected in the first quarter of 2026. Positive findings at this stage could pave the way for accelerated regulatory approval and a commercial launch within the same year. The Phase 3 design closely mirrors the successful Phase 2 trial, which demonstrated clinical efficacy and a favorable safety profile for R327G.

Broader Implications for Synthetic Anti-Infectives

Recce’s R327G is part of a broader pipeline of synthetic anti-infectives designed to combat antibiotic-resistant bacteria. The World Health Organization and the US FDA have recognized Recce’s compounds for their innovative approach and potential to address urgent global health challenges. Success in this Phase 3 trial could not only establish R327G as the first approved topical treatment for diabetic foot infections but also validate the company’s synthetic polymer platform as a new frontier in anti-infective therapy.

Collaborations and Support

The trial benefits from bilateral support by the Indonesian and Australian governments and collaboration with local biomedical partner PT Etana. This multi-stakeholder engagement reflects the strategic importance of the project and may facilitate smoother regulatory and operational processes. Recce’s ownership of automated manufacturing further supports the scalability of production should the therapy gain approval.