Recce Pharmaceuticals Ltd. announced it received Human Research Ethics Committee (HREC) approval to commence a Phase II trial assessing its lead candidate, RECCE 327 (R327), as a topical, broad-spectrum gel for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The Phase II trial is an open-label, efficacy study and exploratory evaluation of the systemic bioavailability of single and/or multiple doses of R327 topical gel applied to ABSSSI. The study aims to provide critical data on the R327?s effectiveness in treating a broad range of ABSSSI indications.

ABSSSI refers to a bacterial infection of the skin and its related tissues. Examples of skin conditions commonly included in that category are diabetic foot infections (DFI), necrotizing fasciitis, post-operative wound infections, and more. This study approval allows the Company to bring together the clinical studies of DFIs, wound infections, and more under one key centralized regulatory category of ABSSSI for a broad range of unmet medical needs in the topical bacterial infection landscape.

This centralized approach has been made possible by building upon the validated study data to date, including compelling patient outcomes under the TGA Special Access Scheme Category A initiatives. The study is to be commenced at Barwon Health, one of the largest and most comprehensive regional health services in Australia, working alongside existing leading healthcare providers to broaden the scope of its topical administration. This will enable the trial to access a diverse patient population and provide valuable insights into R327?s performance across various ABSSSI conditions.

ABSSSIs present a considerable challenge to the healthcare system. While new antibiotic treatments have recently been developed to combat Gram-positive organisms, there remains a crucial need for antibiotics to address both Gram-positive and Gram-negative pathogens. Furthermore, the rise of antimicrobial resistance in both Gram-positive and Gram-negative bacteria, particularly methicillin-resistant Staphylococcus aureus (MRSA), presents a growing challenge in treating these infections with a particular focus on the increase in the prevalence of MRSA being detected among hospitalized patients.

Those particularly at high risk of skin infections and poor outcomes from ABSSSI are patients with diabetes.