Recce Pharmaceuticals Ltd. is advancing its synthetic antibiotic RECCE 327 to a pivotal Phase 3 clinical trial in Indonesia for treating diabetic foot infections (DFIs). The trial, evaluating RECCE 327 as a topical gel (R327G), is expected to commence in the first quarter of 2025.
Trial Design and Objectives
The Phase 3 trial is designed as a double-blinded, placebo-controlled study and is set to enroll up to 300 patients. The trial aims to assess the efficacy and safety of R327G in treating DFIs. Results from the trial are anticipated in late 2025, potentially leading to regulatory approval and commercial launch in the first half of 2026.
Significance of the Trial
Indonesia has one of the world's largest diabetes patient populations, with over 19.5 million adults living with the disease. This creates an urgent need for innovative therapies to address diabetes-related infections, including foot infections. The trial represents one of the largest DFI studies globally and the first of its kind in Indonesia.
Regulatory and Ethical Approvals
Recce has received approval from Indonesia’s National Agency of Drug and Food Control (Badan POM) to initiate the Phase 3 clinical trial. This approval follows recent human ethics committee approval to start patient dosing, highlighting the alignment of Recce’s clinical research with regulatory and ethical standards within Indonesia.
Statements from Key Stakeholders
Indonesian Food and Drug Authority Chairperson Dr. Taruna Ikrar emphasized the importance of the trial, stating that the approval is a significant step in advancing treatment options for DFIs in Indonesia. Recce CEO James Graham noted that the approval brings Recce closer to commercialization and profitability.
Broader Implications
Recce is also conducting a Phase 2 trial for acute bacterial skin and skin structure infections (ABSSSI), which is in its final stages and expected to conclude this year. The company plans to initiate a Phase 3 registrational study of R327G in Australia for ABSSSI in the first half of 2025. A parallel program across the ASEAN region, focused initially on DFIs, allows for an expansive international strategy, bringing near-term revenue opportunities to the forefront.
