‘Significant’ new milestone for Recce in clinical testing of skin infection gel

Recce Pharmaceuticals Ltd (ASX:RCE) has seen its share price move up more than 1% on Tuesday’s news that the company successfully dosed all 30 participants in its Phase II clinical trial of a gel to treat skin infections.

The trial – whose full set of clinical results will be published in 2025’s first quarter – is evaluating the safety, effectiveness, and plasma pharmacokinetics of RECCE 327 Topical Gel as a topic treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI).

Accordingly, participants have had the gel applied once daily to an area affected by ABSSSI for seven to 14 days, with interim data showing no “Serious Adverse Events,” and patients dosed achieving positive outcomes.

Recce will next roll out a Phase III trial of the gel in Australia in the first half of 2025, with this to serve as a registrational trial for the U.S. Food and Drug Administration and Australian Therapeutic Goods Administration.

The company has also been approved for Registrational Phase III trials on the same gel, this time targeting diabetic foot infections (DFI) in Indonesia; this would be one of the largest DFI studies in the world.

Recce CEO James Graham said interim information from the Phase III trial was promising.

“R327G has made significant progress over the last year, confirming its safety profile and demonstrating impressive efficacy as a topical gel formulation, especially considering the high degree of bacterial resistance present in many of the patients being treated in this Phase II trial,” he said.

“We look forward to the full dataset, which we expect will further support R327G’s progress toward regulatory evaluation.”

Recce shares last traded at 47.5 cents, a rise of 1.06% since market open.

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