Recce Pharmaceuticals (ASX:RCE) moves into Phase 3 with Indonesian diabetic foot infection trial

Recce Pharmaceuticals (ASX:RCE) has taken a decisive step forward in its clinical program, commencing patient dosing in its registrational Phase 3 trial for diabetic foot infections (DFI) in Indonesia.

With five clinical sites now activated across one of the largest DFI patient populations globally, the company has placed itself at the centre of a major public health challenge.

Highlights

• Patient dosing underway in registrational Phase 3 DFI trial across five Indonesian sites

• Interim analysis expected Q1 2026, with potential for accelerated approval and commercial launch the same year

• Market opportunity underpinned by 20.9 million adults living with diabetes in Indonesia, equivalent to more than one in ten of the adult population

• Trial enrolment target of up to 310 patients, designed around FDA-recognised Lipsky Scale outcomes

ChatGPT said:

The Indonesian protocol, approved by the national regulator Badan POM, includes an interim analysis with expedited review status, meaning that clinical data could accelerate the regulatory pathway.

The independent data management committee is tasked with completing the interim analysis and providing recommendations within the first quarter of 2026.

Chief executive James Graham said

“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 underway. 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 scale of the opportunity in Indonesia is stark, with more than 20.9 million adults, or 11.3 per cent of the country’s adult population, living with diabetes and ranking the nation fifth globally in prevalence.

As roughly 60 per cent of diabetic foot ulcers progress to infection with serious risks of sepsis, gangrene, amputation, or death, the urgent medical need for novel therapies underscores the potential public health impact of a successful outcome.

Regulatory changes in Indonesia have improved the environment for foreign pharmaceutical companies, reducing approval timelines and costs associated with conducting clinical trials.

This has created conditions favourable for Recce, with the Phase 3 program described as one of the largest DFI studies globally, and the initiative is further supported through bilateral backing from both the Indonesian and Australian governments in partnership with local biomedical collaborator PT Etana.

The program builds on positive Phase II results, where R327G demonstrated efficacy in acute bacterial skin and skin structure infections, including DFI patients, with no signal of serious safety concerns.

The Phase 3 trial has been designed with minimal changes from the successful Phase II framework, reflecting confidence in the earlier findings.

Beyond the trial itself, Recce Pharmaceuticals continues to advance a broader pipeline of synthetic anti-infectives.

Its candidates R327, R435, and R529 have been recognised by both the World Health Organization and the FDA for their potential to address antimicrobial resistance, a problem of mounting concern in global health policy.

The FDA has already granted R327 Fast Track designation and market exclusivity under the Generating Antibiotic Initiatives Now (GAIN) Act, further strengthening its regulatory positioning.

The conclusion of the Indonesian trial will be closely watched, and if the interim analysis in 2026 confirms a statistically significant positive outcome, Recce has indicated it will pursue accelerated approval with a potential commercial launch within the same year.

Against the backdrop of one of the world’s largest diabetes populations, the implications of such an outcome would extend beyond commercial considerations to the broader challenge of infectious disease management.

Please note the following valuable information before using this website. 

Independent Research 

Market Open Australia is intended to be used only for educational and informative purposes, and any information on this website should not be taken as investment advice or guidance. It is important to conduct your own research before making any investment decisions, which should be based on your own investment needs and personal circumstances. Any investment decisions based on information contained on this website should be taken in line with independent financial advice from a qualified professional or should be independently researched and verified.