Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has begun patient dosing in its registrational Phase 3 clinical trial of RECCE® 327 Topical Gel (R327G) for diabetic foot infections (DFI) in Indonesia, marking a major step towards potential commercialisation of its lead anti-infective.
Five clinical study sites have now been activated, with enrolment under way for up to 310 patients who will receive either R327G or placebo. The trial’s primary endpoint is clinical response based on the FDA-recognised Lipsky Scale, with secondary measures including total wound score and safety.
An interim analysis is expected in the first quarter of 2026. If the Independent Data Management Committee confirms a positive outcome after dosing roughly half the patient cohort, Recce intends to pursue accelerated approval — positioning for a potential commercial launch later in 2026.
Addressing a significant market
Indonesia has one of the world’s largest diabetic populations, with an estimated 20.9 million adults — more than one in 10 of the nation’s adult population — living with the disease. Around 60% of diabetic foot ulcers develop infections, which can escalate to sepsis, gangrene, amputation or even death.
“Thanks to the positive engagements with Indonesia’s Food and Drug Authority (Badan POM), we are pleased to have successfully activated multiple leading clinical sites across Indonesia, and the Registrational Phase 3 DFI patient dosing is under way,” said Recce CEO James Graham.
“With R327G positioned as the first potential treatment for DFI, we see ourselves well positioned to meet the infectious disease challenges among the global rise in diabetes.”
The Indonesian Drug and Food Regulatory Authority has granted expedited review status to the trial protocol, which also features a built-in interim analysis. The study is bilaterally supported by both the Indonesian and Australian governments, and by Recce’s local partner PT Etana.
Building on Phase 2 data
The Phase 3 study builds on earlier Phase 2 findings in which R327G demonstrated clinical efficacy in patients with acute bacterial skin and skin structure infections, including those with DFI. The drug was well tolerated, with no serious safety signals observed.
Recce recently reported positive preclinical data showing R327G accelerated burn wound healing in infection models, further supporting its potential as a broad-spectrum topical therapy.
Read more: Recce Pharmaceuticals’ topical gel speeds burn wound healing in infection models
Pipeline progress
The company is advancing a pipeline of synthetic anti-infectives aimed at combating antimicrobial resistance. Alongside R327G, intravenous and oral formulations of RECCE® 327 are being developed, while RECCE® 435 targets bacterial infections and RECCE® 529 is in development for viral diseases.
Recce’s candidates have secured multiple regulatory recognitions, including US FDA Fast Track Designation and 10 years of market exclusivity under the GAIN Act, as well as inclusion on the World Health Organization’s antibacterial pipeline list.
With Phase 3 dosing underway and a potential path to accelerated approval in one of the world’s highest-prevalence diabetes markets, Recce is entering a pivotal stage in bringing its lead anti-infective therapy to patients.