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Recce Pharmaceuticals Ltd (ASX:RCE) has reached the halfway mark in dosing participants in its Phase II Acute Bacterial Skin and Skin Structure Infections (ABSSSI) clinical trial.
The company has dosed 15 patients in the trial so far, which is seeking to assess the efficacy and safety of its RECCE 327 topical gel (also known as R327G) in relation to treatment of ABSSSI, which includes diabetic foot infections (DFI) and other wound infections.
Evidence from the dosing has shown the gel to be safe and well-tolerated across human subjects, with signs of positive antibacterial responses in patients. The data is expected to provide an opening for R327G to be applied in different formulations.
Given the seriousness of ABSSSIs, the market for its treatment is also strong: estimated at USD $1.34 billion in 2023, with this to grow to USD $2.31 billion in the next 10 years.
The Phase II clinical trial – which aims to enrol 30 participants this year – is an open-label pilot efficacy study looking at the bioavailability of single and/or multiple doses of the gel when applied to ABSSSIs.
In particular, it will be looking at systematic absorption of R327G when applied directly to the infected area.
Recce chief executive officer James Graham said the company had reached an important stage in assessment of the gel.
“We are thrilled to pass the halfway point of this pivotal Phase II clinical study for the unmet clinical need of topical skin infections,” he said.
“Indications of promising antibacterial effect is a significant achievement, with patient recruitment to be completed within the year.”
Investors seemed happy with the news, and at 14:50 AEDT, Recce shares were trading at 55.5 cents – a rise of 3.74% since the market opened.
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