Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has garnered Human Research Ethics Committee (HREC) approval to commence a Phase 2 clinical trial of RECCE® 327 (R327) Gel for acute bacterial skin and skin structure infections (ABSSSI).
The trial positions R327 Gel as a potential broad application therapeutic for all bacterial skin infections, including complicated skin and soft tissue infections.
Range of skin infections targeted
An open-label efficacy study and exploratory evaluation, the trial will assess the systemic bioavailability of single and/or multiple doses of R327 topical gel applied to ABSSSI.
These infections include diabetic foot infections (DFI), necrotising fasciitis and post-operative wound infections, among others.
The study aims to provide critical data on the gel's effectiveness in treating a broad range of ABSSSI indications.
Recce Pharmaceuticals CEO James Graham said: "Obtaining HREC approval marks another significant milestone for Recce and the clinicians striving to discover an effective treatment for ABSSSIs.
“This accomplishment highlights Recce's history of successful HREC approvals and underscores the dedication of our clinical and research team as we advance our topical treatment programs."
The company is collaborating with Barwon Health, one of the largest and most comprehensive regional health services in Australia, to conduct the trial.
This partnership will enable the trial to access a diverse patient population and provide valuable insights into the gel's performance across various ABSSSI conditions.
First patients to be dosed this year
New site initiation has already begun, with the first patients expected to be dosed in the third quarter of the year.
This centralised study approach builds on clinical results received from testing R327 against infected burn wounds and diabetic foot infections, including patients treated under the Therapeutic Goods Administration (TGA) Special Access Scheme Category A initiative.
By bringing together the clinical studies of DFIs, wound infections and more under one key regulatory category of ABSSSI, Recce aims to address a broad range of unmet medical needs in the topical bacterial infection landscape.
Bacterial skin infections
ABSSSIs present a considerable challenge to the healthcare system. While new antibiotic treatments have 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, particularly methicillin-resistant Staphylococcus aureus (MRSA), presents a growing challenge in treating these infections. Diabetic patients are particularly at high risk of skin infections and poor outcomes from ABSSSI.
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 (CAGR) of 9.5% between 2019 and 2032.