Recce Receives Ethics Approval to Start Phase 3 Trial of New Diabetic Foot Infection Gel in Indonesia

Recce Pharmaceuticals Limited, a company pioneering a new class of synthetic anti-infectives, is excited to announce it has obtained Human Research Ethics Committee approval to initiate a registrational Phase 3 clinical trial of its topical gel, RECCE® 327 (R327G), for diabetic foot infections (DFI).

This ethics approval confirms Recce has successfully met the safety and efficacy benchmarks necessary to advance into this large-scale, late-stage clinical trial. The trial, set to begin in mid-December, will be a double-blind, placebo-controlled study designed to assess the effectiveness of R327G in treating DFIs. The study plans to enroll up to 300 participants, with 200 receiving R327G and 100 receiving a placebo.

The trial is set to span roughly 12 months, with initial results anticipated by late 2025 and a projected regulatory approval and commercial launch in the first half of 2026. This study is being conducted with substantial backing from essential Indonesian partners, including the Ministry of Health, Badan POM, PT Etana Biotechnologies, and support from the Australian Government, streamlining R327G's journey to market. Recce anticipates study costs around US$2 million, with the Australian government’s R&D rebate of 43.5% through the Advanced Overseas Advanced Finding scheme with AusIndustry offsetting a portion. All intellectual property rights remain with Recce.

Indonesia's approval process for clinical trials requires two key authorizations: ethics approval, already secured, and BPOM approval, expected shortly. Completion of this trial would open doors for Recce to pursue regulatory approvals across the wider ASEAN region, including countries like Malaysia, the Philippines, Singapore, and Thailand. This expansion would address a vital need for innovative treatments in regions battling rising rates of antimicrobial resistance and infectious diseases.

The clinical trial will begin at PT Siloam International Hospitals, Indonesia's largest private hospital network, known for its extensive healthcare services in hospitals and clinics across numerous cities nationwide. This regulatory approval for initiating a registrational Phase 3 clinical trial for diabetic foot infection (DFI) follows promising results from an Acute Bacterial Skin and Skin Structure Infections (ABSSSI) study conducted in Australia, where the R327G treatment achieved a 100% patient response rate, showing complete infection cure or improvement.

For individuals with diabetes, the likelihood of developing a foot ulcer can be as high as 34%, and nearly half of these cases lead to infection. These infections can escalate to severe outcomes such as sepsis, gangrene, amputation, or even death. The diabetic foot infection treatment market is valued at around US$5.2 billion globally. Targeting Indonesia’s market, estimated at approximately US$189 million, is particularly strategic, with diabetes affecting 11% of the population annually. Approval in Indonesia would enable further expansion into the Asia-Pacific region, a market worth nearly US$1.0 billion per year.

Recce Pharmaceuticals Chief Executive Officer, James Graham, said in a statement, “Today marks the achievement of a landmark milestone in Recce’s clinical program development. We are thankful for the unparalleled support from our Indonesian partners in bringing our innovative anti-infective therapy to patients in need. This welcomed approval signals the beginning of our clinical programs in Indonesia and the broader ASEAN region, bringing Recce one step closer to commercialisation. We look forward to evaluating R327G in our first Phase 3 trial.”