How Is Recce Pharmaceuticals Advancing Its Phase 3 Trial in Indonesia?
Recce Pharmaceuticals has commenced patient dosing in its pivotal Phase 3 trial for diabetic foot infections in Indonesia, supported by promising antibacterial efficacy data and extended funding arrangements.
- Phase 3 clinical trial underway with multiple Indonesian sites activated
- R327 topical gel shows significant efficacy against antibiotic-resistant bacteria
- Featured in WHO’s 2025 Global Antibacterial Pipeline Report
- Cash balance of A$3.17 million with extended equity facility to 2031
- Near-term R&D rebate expected to support ongoing clinical and regulatory activities
Phase 3 Clinical Trial Progress
Recce Pharmaceuticals Ltd (ASX – RCE) has taken a significant step forward in its development pipeline by initiating patient dosing in its registrational Phase 3 clinical trial targeting diabetic foot infections (DFI) in Indonesia. With five clinical sites now activated, the study aims to enrol up to 310 patients to evaluate the safety and efficacy of its synthetic anti-infective, RECCE® 327 Topical Gel (R327G). The trial’s primary endpoint uses the Lipsky Scale, a clinically recognised measure endorsed by the FDA for assessing diabetic foot infection outcomes.
This trial is notable not only for its scale; being among the largest DFI studies globally; but also for its strategic focus on Indonesia, a country with one of the highest diabetes prevalence rates worldwide. Over 20 million adults in Indonesia live with diabetes, creating a substantial unmet need for innovative treatments to address infections that frequently complicate diabetic foot ulcers.
Compelling Antibacterial Efficacy Data
Recce’s R327G has demonstrated statistically significant in-vivo efficacy against two critical antibiotic-resistant pathogens – Methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa. These bacteria are among the most challenging in chronic wound infections and are listed by the World Health Organization as high-priority drug-resistant threats.
In animal models, R327G achieved up to a 99.9% reduction in MRSA and a 99.99% reduction in Pseudomonas aeruginosa bacterial loads by Day 8, outperforming a standard topical antibiotic comparator. Moreover, the gel accelerated wound healing without adverse effects, underscoring its potential as a broad-spectrum topical therapy.
Global Recognition and Strategic Funding
Recce’s innovative approach has earned it a place in the World Health Organization’s 2025 Global Antibacterial Pipeline Report, highlighting R327 as the only synthetic polymer antibiotic in clinical development with a novel mechanism disrupting bacterial energy production. Additionally, the company showcased expanded data at the 2025 United States Military Health System Research Symposium, demonstrating activity against several high-priority bioterrorism pathogens, further validating its broad-spectrum potential.
Financially, Recce closed the quarter with A$3.17 million in cash and reported net operating cash outflows of A$6.92 million, primarily due to ongoing research and development activities. The company has extended its At-the-Market equity subscription agreement with Acuity Capital until 2031, providing standby capital flexibility. Importantly, Recce anticipates a near-term cash inflow from an Australian Government R&D rebate, which should bolster its funding runway and support continued clinical and regulatory progress.
Looking Ahead
With the Phase 3 trial on track for an interim data readout in the first quarter of 2026, Recce is positioned for multiple upcoming catalysts. The combination of robust clinical data, regulatory engagement in Indonesia, and financial backing sets the stage for potential expedited approval pathways and commercial advancement. Investors will be watching closely as these developments unfold.
Bottom Line?
Recce’s clinical momentum and strategic funding position it well for pivotal data and regulatory milestones in 2026.
Questions in the middle?
- When exactly will the interim Phase 3 data be released, and what early signals might it provide?
- How will regulatory authorities in Indonesia respond to the trial data and potential expedited approval requests?
- What is the timing and amount of the expected R&D rebate, and how will it impact Recce’s cash runway?
