Recce Pharmaceuticals secures approval for Phase 3 trial of R327G in Indonesia

Recce Pharmaceuticals Limited (ASX: RCE) has achieved a significant milestone in its quest to tackle diabetic foot infections (DFIs), a common complication among diabetes patients. The Australian biotech company has received approval from Indonesia’s National Drug and Food Authority, Badan POM, to begin a registrational Phase 3 clinical trial of its synthetic anti-infective drug, RECCE 327, known as R327G. This approval marks the beginning of an important study for the treatment of diabetic foot infections, one of the most challenging and common infections faced by diabetic patients globally.

Indonesia, with a diabetes population exceeding 19.5 million adults, represents a crucial market for addressing diabetes-related complications, including infections like diabetic foot infections. The approval of this Phase 3 clinical trial positions Recce Pharmaceuticals to not only provide a novel solution for Indonesian patients but also advance the company’s commercial opportunities in the ASEAN region. The Phase 3 clinical trial of R327G will be a double-blind, placebo-controlled study, enrolling up to 300 patients, with an expected readout by late 2025.

The trial’s approval in Indonesia comes after a positive ethics review, ensuring the study aligns with both regulatory and ethical standards. Dr. Taruna Ikrar, Chairperson of Badan POM, highlighted the significance of the trial’s approval, emphasizing its potential to expand the treatment options for diabetic foot infections in Indonesia. He also acknowledged the importance of fostering timely innovation to address urgent healthcare challenges in the region.

Breaking ground for novel treatments in Indonesia

R327G is set to become one of the largest studies focused on diabetic foot infections, marking Indonesia’s first-ever registrational Phase 3 clinical trial for this condition. The trial will evaluate the safety and efficacy of R327G as a topical gel treatment, targeting the growing number of people suffering from diabetic foot infections in the region. With the Indonesian healthcare system facing a mounting need for innovative therapies, this study is a pivotal step in addressing a public health crisis.

In addition to this, the trial in Indonesia is part of Recce’s broader international strategy, which includes plans for parallel studies in other ASEAN countries and Australia. In 2025, Recce is set to launch a Phase 3 registrational study of R327G in Australia, expanding the reach of its innovative therapies across the region.

A game-changing opportunity for Recce Pharmaceuticals

For Recce Pharmaceuticals, the approval for the Phase 3 clinical trial of R327G in Indonesia is not just a regulatory win but a significant step toward commercialization and profitability. CEO James Graham emphasized that this approval brings the company closer to achieving its goal of making R327G a commercially available treatment. Graham also acknowledged the critical support from the Indonesian Ministry of Health, Badan POM, and key stakeholders like PT Etana Biotechnologies, which have played a pivotal role in expediting the trial’s approval process.

The trial is expected to run for approximately 12 months, with the company forecasting regulatory approval and potential commercial launch in the first half of 2026. The financial backing provided by the Australian government’s R&D rebate scheme, along with the partnership of key Indonesian stakeholders, is expected to significantly subsidize the trial’s cost, making the trial more feasible for Recce Pharmaceuticals.

Key takeaways

Recce Pharmaceuticals’ approval to proceed with the Phase 3 clinical trial of R327G in Indonesia highlights the growing importance of innovation in the fight against diabetic foot infections. The trial will provide much-needed data on the effectiveness of R327G as a topical treatment, offering hope to millions of patients suffering from this serious condition. As the trial progresses, Recce is positioning itself as a leader in the development of novel anti-infectives aimed at treating complex and life-threatening infections.

This pivotal trial also underscores the growing collaboration between Australian and Indonesian healthcare sectors, as both countries work together to tackle urgent medical challenges in the region. With the backing of both governments and significant stakeholders, Recce Pharmaceuticals is poised to make a substantial impact on global health.