Recce Pharmaceuticals Advances to Phase 3 Trial for Diabetic Foot Infection Treatment in Indonesia

Highlights

• Ethics Approval for Phase 3 Trial: Recce Pharmaceuticals received approval to initiate a large-scale Phase 3 trial in Indonesia for its RECCE® 327 (R327G) topical gel targeting diabetic foot infections.
• 300-Patient Study Begins in December: The trial, set to launch in mid-December, will be double-blinded and placebo-controlled, with completion expected by late 2025.
• Strategic Regulatory Progress: The Indonesian study benefits from local government support and aims for ASEAN-wide regulatory traction, with commercial launch projected for early 2026.

Recce Pharmaceuticals Ltd (ASX:RCE) has reached a significant milestone in its development of a topical treatment for diabetic foot infections (DFIs), with the company recently securing Human Research Ethics Committee approval to proceed with a Phase 3 clinical trial for RECCE® 327 (R327G). This approval will allow dosing to commence in Indonesia for the drug’s Registrational Phase 3 study, marking an important advance toward addressing severe infections linked to diabetes complications.

The large-scale trial will begin in mid-December and will be conducted as a double-blinded, placebo-controlled study with approximately 300 participants across various sites in Indonesia. The study will span 12 months, and its findings are anticipated by the end of 2025. If successful, the trial results could lead to regulatory approval and a commercial launch as early as the first half of 2026, helping to provide an effective, market-ready solution for DFIs.

CEO James Graham shared insights on the trial during a recent interview with Proactive’s Tylah Tully, emphasizing the importance of this clinical phase. The trial is not only a significant step for Recce Pharmaceuticals but also aligns with public health needs in Indonesia, which faces high rates of diabetes and an increasing burden of antimicrobial resistance. Graham noted that Indonesian approval could set the stage for further regulatory clearances across the ASEAN region, potentially broadening R327G’s availability to neighboring countries facing similar healthcare challenges.

Recce’s Indonesian trial is facilitated by PT Etana Biotechnologies and has garnered support from both the Australian and Indonesian governments. With a projected cost of $2 million USD, the trial will be partially offset by Australia's R&D rebate program, helping to ease financial pressures as the company advances its innovative product. Additionally, Recce expects to receive imminent approval from BPOM, Indonesia’s food and drug authority, further paving the way for trial commencement and future market entry.

The decision to conduct this trial in Indonesia reflects a strategic approach to addressing an unmet need in regions with high diabetes prevalence and increasing resistance to conventional antibiotics. Encouraging early trials in Australia revealed a 100% response rate in patients, adding to the drug’s promise in treating severe infections in diabetic foot ulcers.

In addition to this Phase 3 development, Recce Pharmaceuticals has reported considerable progress in its ongoing Phase II trial for R327G in treating Acute Bacterial Skin and Skin Structure Infections (ABSSSI). With 20 out of 30 patients already dosed, the trial has met primary endpoints in all patients, indicating either a cure or marked improvement, without any Serious Adverse Events (SAEs) reported. This Phase II study is expected to conclude by the end of 2024, bolstering confidence in R327G’s potential to meet critical unmet needs in bacterial infection treatment.

Recce’s development trajectory for R327G continues to gain momentum, supported by regulatory endorsements and promising data that underscore the drug's safety and efficacy. If successful, R327G could provide a new treatment avenue for infections that are increasingly difficult to manage with traditional antibiotics.