Recce Pharmaceuticals' RECCE 327 Gel Receives Approval for Phase III Diabetic Foot Infection Trial in Indonesia

• Recce Pharmaceuticals has received ethics approval in Indonesia to begin a Phase III trial of RECCE 327 (R327G) topical gel for diabetic foot infections (DFI).
• The double-blinded, placebo-controlled study will enroll up to 300 patients to assess the safety and efficacy of R327G, with results expected by late 2025.
• This trial is supported by Indonesian stakeholders and follows positive Phase II results in Australia for acute bacterial skin infections using R327G.
• Recce anticipates regulatory approval and commercial launch of R327G in the first half of 2026, retaining all intellectual property rights.

Recce Pharmaceuticals has secured approval from the Human Research Ethics Committee in Indonesia to commence a Phase III registrational trial of its RECCE 327 (R327G) topical gel for the treatment of diabetic foot infections (DFI). The trial is set to begin in mid-March.

The double-blinded, placebo-controlled study will evaluate the safety and efficacy of R327G in treating DFIs. The trial aims to enroll approximately 300 patients, with 200 receiving R327G and 100 receiving a placebo.

Trial Design and Anticipated Outcomes

The 12-month trial is expected to yield results by the end of 2025. Recce Pharmaceuticals anticipates securing regulatory approval and subsequently launching the product commercially in the first half of 2026. The trial receives support from various Indonesian entities, including the Ministry of Health, Badan POM, PT Etana Biotechnologies, and the Australian Government, with an estimated cost of $2 million, partially offset by a 43.5% research and development rebate from the Australian Government.

Supporting Data and Ongoing Research

This Phase III trial follows promising results from an ongoing Phase II study in Australia, where R327G demonstrated a 100% patient response rate in treating acute bacterial skin and skin structure infections (ABSSSI). Furthermore, Recce Pharmaceuticals initiated patient dosing in a Phase I/II proof of concept (PoC) study of RECCE 327 (R327) for treating DFI in August of the previous year.

Executive Commentary

Recce Pharmaceuticals CEO James Graham expressed gratitude for the support from Indonesian partners, stating, "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, a prominent hospital network in Indonesia, will host the initial trial.