Recce Pharmaceuticals (ASX:RCE) has received Human Research Ethics Approval (HREC) to enrol up to 20 additional patients with Diabetic Foot Infections (DFI) in its Phase 2 trial of R327G.
The company said the use of R327G under this protocol follows strong interest by investigators, encouraged by the highly promising results of the recently released Phase 2 data. It said R327G, after 7 days of treatment, 86 per cent of patients treated had a successful clinical response, and at 14 days of treatment, over 90 per cent achieved a primary efficacy endpoint.
Recce said the study can further strengthen the clinical profile of R327G while addressing the urgent needs of patients lacking effective treatment options. The study will start now and run in parallel with Recce's Indonesian Phase 3 trial, which will commence shortly. It said the program does not impact the initiation timeline of the Registrational Phase 3 DFI study in Indonesia or the planned Registrational Phase 3 for ABSSSI in Australia. It is designed to run in parallel and is expected to generate additional data to support future regulatory submissions.
Barwon Health will conduct the study.
Recce CEO James Graham said, "This approval allows us to build upon the strong clinical results of R327G and continue demonstrating its potential as a differentiated treatment for DFIs. We are pleased to continue to provide access to R327G to diabetic patients in need, and to further build out our data portfolio alongside our Phase 3 programs in both Australia and Indonesia."
