Phase 3 Trial Begins for Topical Gel for Diabetic Foot Infections

Recce Pharmaceuticals recently announced that patient dosing is underway for its phase 3 clinical trial in Indonesia, with 5 clinical trial sites activated. Participants will be randomly assigned to receive either the company's investigational R327G topical gel or placebo. The trial’s primary objective is to assess the clinical response of the diabetic foot infections (DFIs) according to the Lipsky scale. Recognized by the US Food and Drug Administration, the Lipsky scale is a valid and reliable method for evaluating the treatment outcomes for DFIs.

“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,” Recce Pharmaceuticals CEO James Graham said in a statement.

Indonesia’s DFI Burden, Secondary End Points

With patient dosing underway, the company is targeting enrollment of up to 310 patients with DFI, which would make it one of the largest studies of its kind in the world. This is the first-ever phase 3 DFI trial in Indonesia, addressing a critical unmet need where diabetes affects more than 20.9 million adults, or more than 10% of the population.

In terms of secondary end points, these include a DFI total wound score and safety of R327G, including clinical observations and adverse events. Based on the approved statistical plan, the company’s phase 3 study for DFI expects to meet a highly statistically significant positive end point after dosing approximately 155 patients. The Badan POM protocol has a built-in interim analysis as well as expedited regulatory review status.

Watch a previous video interview with Graham below.

About Their Products

The company, based in Sydney, Australia, has developed a new class of synthetic anti-infectives, and R327G is being studied as an intravenous and topical therapy for the treatment of serious and potentially life-threatening infections due to gram-positive and gram-negative bacteria. Additionally, the company has developed R435, which is an orally administered therapy for bacterial infections and R529 for viral infections. Through their multilayered mechanisms of action, the company says its anti-infectives have the potential to overcome the processes utilized by bacteria and viruses to overcome resistance.¹

Earlier this year, Recce reported positive findings from its phase 2 study examining the efficacy and safety of R327G in patients with acute bacterial skin and skin structure infections, including those with DFI. R327G demonstrated a 93% primary efficacy end point over 14 days, meeting all study end points.²

Study Analysis Timeline

The program is supported Badan POM, local partner PT Etana Biotechnologies, and is bilaterally supported by the Australian and Indonesian governments.¹

Interim analysis is expected in the first quarter of 2026, with a submission for accelerated approval and potential commercial launch in 2026 pending positive results. ¹

“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,” Graham said.¹

References
1. Patient dosing and multiple sites activated in registrational phase 3 clinical trial for diabetic foot infections in Indonesia. Press release. Reece. September 25, 2025. Accessed October 2, 2025. https://www.recce.com.au/company-announcements/

2. Parkinson J. Recce Pharmaceuticals reports positive data from phase 2 study for its gel for ABSSSI. Contagion. February 19, 2025. Accessed October 2, 2025. https://www.contagionlive.com/view/recce-pharmaceuticals-reports-positive-data-from-phase-2-study-for-gel-for-absssi