R327G is a topical gel treatment being analysed for diabetic foot infections. Credit: Olga Apanasenko/Shutterstock.

Recce Pharmaceuticals (Recce) has obtained approval from the Human Research Ethics Committee in Indonesia to initiate a registrational Phase III trial of its RECCE 327 (R327G) as a topical gel treatment for diabetic foot infections (DFI).

Set to begin mid-next month, the double-blinded, placebo-controlled study will assess the safety and efficacy of R327G.

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It aims to enrol up to 300 patients, with approximately 200 patients expected to be treated with R327G and the remaining 100 will receive a placebo.

Results from the 12-month trial of R327G are anticipated by the end of 2025.

The company expects to obtain regulatory approval, followed by the subsequent commercial launch of the product, in the first half of 2026.

The trial is supported by Indonesian stakeholders, including the Ministry of Health, Badan POM, PT Etana Biotechnologies, and the Australian Government.

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The trial is estimated to cost approximately $2m, before accounting for a 43.5% research and development rebate from the Australian Government under the company’s Advanced Overseas Advanced Finding status with AusIndustry.

Recce retains all intellectual property rights associated with the product.

Recce Pharmaceuticals CEO James Graham said: “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 III trial.”

PT Siloam International Hospitals, Indonesia’s hospital network, will host the initial trial.

This move follows an ongoing Phase II study in Australia for acute bacterial skin and skin structure infections (ABSSSI), where treatment with R327G resulted in a 100% patient response rate, curing or improving all infections.

In August last year, the company commenced patient dosing in a Phase I/II proof of concept (PoC) study of RECCE 327 (R327) to treat DFI.