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Recce receives green light to conduct registrational phase III clinical trial in Indonesia for diabetic foot infections

Recce awarded expedited regulatory review status in Indonesia to fast-track progression of trial

Company on track to start trial this quarter

Special Report: Recce Pharmaceuticals has received approval from Indonesia’s National Agency of Drug and Food Control to initiate its registrational phase III clinical trial assessing RECCE 327 as a topical gel for the treatment of diabetic foot infections.

Recce Pharmaceuticals (ASX:RCE) said approval to conduct the trial in Indonesia, which has one of the world’s largest diabetes patient populations, represents a significant milestone.

The approval by the country’s National Agency of Drug and Food Control (Badan POM) follows recent human ethics committee approval to start patient dosing, underscoring the alignment of Recce’s clinical research with regulatory and ethical standards within Indonesia.

With both approvals now secured, Recce said it remained on track to start the registrational phase III clinical trial this quarter.

Recce is focused on developing a new class of synthetic anti-infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.

Advancing treatment options for DFIs in Indonesia

Recce said starting its registrational phase III trial of RECCE 327 as a topical gel (R327G) in diabetic foot infections (DFIs) in Indonesia was not only significant for its growth but would also contribute positively to the Asian nation’s healthcare landscape.

The company said with more than 19.5 million adults living with diabetes in Indonesia, the need for innovative therapies to address diabetes-related infections – including foot infections, urinary tract infections and surgical site infections – was urgent.

Recce said the phase III trial was one of the largest DFI studies in the world and the first of its kind across Indonesia.

Indonesian Food and Drug Authority Chairperson Dr Taruna Ikrar said the approval of the phase III trial is an important step in advancing treatment options for DFIs in Indonesia.

“Badan POM is committed to supporting the timely development of innovative therapies to address this critical health challenge,” Dr Ikrar noted.

“This collaboration aligns with Indonesia’s mission to advance healthcare solutions for our population, and we look forward to seeing the impact of this trial for patients in need of new, effective anti-infective treatments.”

‘Closer to commercialisation and profitability’

Recce CEO James Graham said the approval of the registrational phase III trial from the Indonesian authority was a “significant achievement, bringing Recce closer to commercialisation and profitability”.

“We also acknowledge the support of Investment NSW, Austrade and the Australian embassy team in Jakarta, who played an important role in helping with the approval process,” he said.

“We look forward to evaluating R327G in our first phase III trial.”

The trial will be conducted as a double-blinded, placebo-controlled study on track to begin this month and is set to run for about a year and enrol up to 300 patients ahead of the expected read-out late in 2025 and expected regulatory approval and commercial launch in the first half of 2026.

2025 was already shaping up to be a milestone year for Recce, which is also expecting to start another phase III trial.

Recce’s phase II trial for acute bacterial skin and skin structure infections (ABSSSI) is in the final stages and on track to finish this calendar year.

The company is expected to initiate a phase III registrational study of R327G in Australia in H1 2025 for ABSSSI.

Recce said a parallel program across the ASEAN region focused initially on DFIs allows for an expansive international strategy, bringing near-term revenue opportunities of the region to the forefront.

Recce gets Indonesian nod for phase III trial of diabetic foot infection treatment