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Recce sees progression of Phase 2 study assessing efficacy of RECCE® 327 (R327G) topical gel against acute bacterial skin and skin structure infections

R327G indicates promising antibacterial effects across a broad range of human infections

Clinical study review board remains on track to review the data in mid-October with interim results to follow

Special Report: Recce Pharmaceuticals has announced the successful dosing of half of its targeted 30 patients with RECCE® 327 (R327G) topical gel in its Phase 2 trial for Acute Bacterial Skin and Skin Structure Infections (ABSSSI).

Recce Pharmaceuticals (ASX:RCE) has announced that R327G is showing to be safe and well tolerated in 15 human subjects, with indications of promising antibacterial responses observed in patients.

The company said the initial available data represented a significant opportunity to expand the application of the R327G formulation.

Recce noted that ABSSSIs are a major healthcare concern, with clinical trials addressing indications such as diabetic foot infections (DFI), necrotising fasciitis, and post-operative wound infections.

The global ABSSSI market size was estimated at US$1.34bn in 2023 and is expected to reach US$2.31bn in the next 10 years.

The Phase 2 clinical trial is an open-label, pilot efficacy study and exploratory evaluation of the systemic bioavailability of single and/or multiple doses of R327 as a topical gel applied to acute bacterial skin and skin structure infections.

Recce said the study aimed to evaluate the efficacy and systemic absorption of R327G when applied directly to the infected area.

The company remains on track to enrol 30 participants within this calendar year. In addition to its lead site 

Barwon Health in Victoria Recce has added two new sites including the Australian Clinical Research Network NSW and ACRN Melbourne.

The clinical study review board reportedly remains on track to review data in mid-October with interim results to follow.

Drug-resistance adds to challenge of treating ABSSSI

Recce is tackling the global health problem of antibiotic-resistant superbugs with its new class of synthetic anti-infectives.

CEO James Graham said the company was thrilled to pass the halfway point of the Phase 2 clinical study for the unmet clinical need of topical skin infections.

“Indications of a promising antibacterial effect are a significant achievement, with patient recruitment to be completed within the year,” he said.

“The market for ABSSSI is expanding due to an increase in the frequency of bacterial skin infections, particularly those caused by drug-resistant strains.”

Graham said the acute lack of effective broad-spectrum antimicrobials significantly contributes to the challenge.

“Together with initial data from the Therapeutic Goods Administration (TGA) Special Access Scheme, which saw dramatic results in several DFI patients, we are excited to complete this trial and, moreover, explore the potential of R327G to impact this growing global healthcare need.”

This article was developed in collaboration with Recce Pharmaceuticals, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Recce’s Phase 2 trial for skin infections hits midway recruitment milestone