Recce kicks off patient dosing in Phase 3 trial of diabetic foot infections in Indonesia

• Patient dosing is underway for Recce’s registrational Phase 3 trial of R327G for diabetic foot Infections
• Five sites activated in Indonesia, which has one of the world’s largest patient populations of diabetic foot infections
• Interim analysis expected Q1 2026 with positive outcome enabling possible accelerated approval and launch in same year

Special Report: Recce Pharmaceuticals has achieved a key milestone with patient dosing underway in its registrational Phase 3 clinical trial of RECCE Topical Gel (R327G) in diabetic foot infections (DFIs) in Indonesia.

Leading developer of a new class of synthetic anti-infectives Recce Pharmaceuticals (ASX:RCE) said clinical trial sites were now activated and the study was on track for a Q1 2026 readout.

The company’s registrational trial is one of the world’s largest DFI studies, targeting enrolment of up to 310 DFI patients randomised to receive either R327G or placebo.

The trial’s primary objective is to assess clinical response to DFI using the Lipsky Scale, a valid and reliable method recognised by the US Food and Drug Administration FDA for evaluating treatment outcomes in diabetic foot infections.

Secondary endpoints include total DFI wound score and safety of R327G, including clinical observations and adverse events.

According to the approved statistical plan, Recce said the study for DFI was expected to meet a highly statistically significant positive endpoint after ~155 patients have been dosed.

The protocol – approved by the Indonesian Drug and Food Regulatory Authority (Badan POM or BPOM) – includes a built-in interim analysis and has been granted expedited regulatory review status.

An independent data management committee will complete this analysis and provide recommendations in Q1 2026.

The first patient dosing follows approvals from both Badan POM and the Human Research Ethics Committee (HREC).

The trial is bilaterally supported by both the Indonesian and Australian governments, alongside local Indonesian biomedical collaborator PT Etana.

R327G has previously demonstrated clinical efficacy, curing infections in patients with acute bacterial skin and skin structure infections (including DFI) in a Phase 2 trial as well as other smaller patient efficacy studies.

The drug was well tolerated with no indication of serious safety concerns. Based on these Phase 2 results, the Phase 3 trial was designed with minimal changes to replicate the findings.

Indonesia faces one of world’s highest diabetes burdens

More than 20.9 million adults in Indonesia are living with diabetes, representing ~11.3% of the nation’s adult population or more than one in 10 adults, ranking the country fifth globally for diabetes prevalence.

This is one of the highest rates in Southeast Asia and nearly equivalent to the entire population of Australia, highlighting both the scale of the disease burden and the urgent need for new treatment solutions.

Recce said there was a high need for innovative broad-spectrum therapies to treat diabetes-related infections including DFI, urinary tract infections and surgical site infections.

More than 60% of all diabetic foot ulcers develop infections, which may progress to sepsis, gangrene, amputation, and even death.

In a positive shift, recent Indonesian regulatory changes have shortened approval times for new drugs and lowered costs, making it easier for foreign pharmaceutical companies to conduct clinical trials.

‘First potential treatment for DFI’

CEO James Graham said Recce was well positioned to tackle the challenge diabetes and DFI posed globally.

“With R327G positioned as the first potential treatment for DFI, we believe we are well placed to address the infectious disease challenges linked to the global rise in diabetes,” he said.

“Thanks to our positive engagements with Indonesia’s Food and Drug Authority we are pleased to have successfully activated multiple leading clinical sites across Indonesia, with registrational Phase 3 DFI patient dosing now underway.”

This article was developed in collaboration with Recce Pharmaceuticals, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.