Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has hit its straps in an ongoing Phase 2 clinical trial for acute bacterial skin and skin structure infections (ABSSSI), having dosed 15 patients, marking the halfway point in recruitment.
CEO James Graham said: “We are thrilled to pass the halfway point of this pivotal Phase 2 clinical study for the unmet clinical need of topical skin infections.
“Indications of promising antibacterial effect is a significant achievement, with patient recruitment to be completed within the year.”
Growing global market
ABSSSIs present a large unmet medical need, with an estimated global market of around US$1.34 billion in 2023, which is expected to grow to US$2.31 billion in the next decade.
With an eye on these numbers, the company remains focused on moving R327G through clinical trials to address ABSSSIs such as diabetic foot infections and post-operative wound infections.
The clinical trial has been set up to assess the efficacy and safety of Recce’s synthetic anti-infective, RECCE® 327 topical gel (R327G), in treating severe bacterial skin infections.
Designed as an open-label study, it will also evaluate R327G’s systemic absorption when applied directly to infected areas.
Initial data from the trial has indicated that R327G is both safe and well-tolerated by patients, with promising antibacterial effects observed.
These findings provide a jumping off point to further explore the application of R327G in managing bacterial skin infections.
Study expansion
The study will have enrolled a total of 30 participants by the end of 2024 with recruitment sites expanding across New South Wales and Victoria, including Barwon Health and new locations through the Australian Clinical Research Network in Sydney and Melbourne.
Interim results from the ongoing trial are expected following a clinical study review board in mid-October.
Further updates on the trial’s progress are anticipated as more data becomes available.
“The market for ABSSSI is expanding as a result of an increase in the frequency of bacterial skin infections, particularly those brought on by drug-resistant strains,” Graham continued.
“The acute lack of effective broad-spectrum antimicrobials contributes significantly to this challenge.
“Together with our initial data from the Therapeutic Goods Administrations (TGA) Special Access Scheme, which saw dramatic results in a number of DFI patients, we are excited to complete this trial and moreover, the potential of R327G to impact this growing global healthcare need.”