The company’s R327 gel will be tested for its safety and efficacy against acute bacterial skin and skin structure infections.
Recce Pharmaceuticals has received human research ethics committee approval to start a Phase II clinical trial assessing its R327 product as a topical, broad-spectrum gel applied to acute bacterial skin and skin structure infections.
The Phase II clinical trial is an open-label, efficacy study and exploratory evaluation of the systemic bioavailability of single and/or multiple doses of the gel.
The study aims to provide critical data on the gel’s effectiveness in treating a broad range of ABSSSI indications. Examples of skin conditions commonly included in that category are diabetic foot infections), necrotising fasciitis, post operative wound infections and more.
This study approval allows Recce to bring together the clinical studies of DFI, wound infections and more under one key centralised regulatory category of ABSSSI for a broad range of unmet medical needs in the topical bacterial infection landscape.
The purpose of this study is to evaluate R327 gel clinical efficacy and toxicity.
Recce is working with Barwon Health in Geelong to broaden the scope of its topical administration. This will enable the trial to access a diverse patient population and provide valuable insights on the gel’s performance across various ABSSSI conditions.
“Obtaining HREC approval marks another significant milestone for Recce and the clinicians striving to discover an effective treatment for ABSSSIs,” said Recce Pharmaceuticals CEO, James Graham.
The global ABSSSI treatment market size was valued at US$7.3 billion in 2018 and is projected to reach US$26 billion by 2032, representing a compound annual growth rate of 9.5% between 2019 and 2032.
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 that can address both gram-positive and gram-negative pathogens.
The rise of antimicrobial resistance in both gram-positive and gram-negative bacteria, particularly methicillin-resistant Staphylococcus aureus, presents a growing challenge in treating these infections; with a particular focus on the increase of prevalence of MRSA being detected among hospitalised patients. Those particularly at high risk of skin infections and poor outcomes from ABSSSI are diabetic patients.