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Highlights
- Recce Pharmaceuticals secures ethics approval for Phase 3 trial of R327G in Indonesia.
- Trial targets diabetic foot infections with commercialisation aimed for 2026.
- Bilateral support from Australia and Indonesia enhances trial’s impact in ASEAN region.
Recce Pharmaceuticals Ltd (ASX:RCE) has received ethical approval from the Human Research Ethics Committee to initiate a Phase 3 clinical trial in Indonesia for its innovative anti-infective product, RECCE® 327 (R327) topical gel. This treatment aims to combat diabetic foot infections (DFIs), which are common and often severe complications in diabetic patients. The company has set its sights on potential commercialisation in 2026, with the trial marking a significant step toward providing new therapeutic options for patients in Indonesia and the broader ASEAN region.
Recce Pharmaceuticals CEO, James Graham, highlighted the importance of this development, stating that it is a "landmark milestone" in the company’s clinical program. He emphasized the collaborative efforts with Indonesian partners, which have been essential in bringing R327 to clinical testing in Southeast Asia. According to the company, this approval not only signals the beginning of their clinical efforts in Indonesia but also supports Recce’s commitment to commercializing its anti-infective therapies across ASEAN markets.
The upcoming trial for R327G, a pioneering topical gel, will address bacterial infections, especially those resistant to current treatments. This large-scale trial is designed as a double-blind, placebo-controlled study, set to begin in December and continue for approximately 12 months. The trial will involve 300 patients, of whom 200 will receive R327G and 100 a placebo, with final data expected in late 2025.
Support from both Australian and Indonesian government initiatives is instrumental to the trial’s success, with clinical collaborations in place with PT Etana Biotechnologies and PT Siloam International Hospitals, Indonesia’s largest private hospital network. The Australian Government’s R&D rebate scheme also offsets around 43.5% of the projected US$2 million trial cost, bolstering financial support for Recce’s clinical activities.
Following ethics approval, Recce Pharmaceuticals expects swift progress toward full regulatory authorization from Indonesia’s regulatory body, Badan POM. Success in the Indonesian trial could open doors to other ASEAN markets, including Malaysia, the Philippines, Singapore, and Thailand, where DFI treatment represents a substantial market.
Recce’s broader therapeutic pipeline, including R327G, is focused on antibiotic-resistant infections. With an estimated US$5.2 billion global market for DFI treatments and a growing demand for effective solutions, Recce’s product holds promise. The gel demonstrated 100% response rates in an Australian study, showcasing its potential efficacy in high-risk infections.
By advancing R327G in Indonesia, Recce Pharmaceuticals aims to contribute meaningfully to the fight against antibiotic resistance and meet the urgent need for effective anti-infective treatments in diabetic populations across Southeast Asia.
