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Recce Pharmaceuticals (ASX:RCE) has received a boost to the development of its topical gel for the treatment of diabetic foot infections, as 20 more patients with the condition are added to its Phase II clinical trial of the product, R327G.
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The inclusion of these participants – enabled through Human Ethics Approval – comes on the back of positive results from this open-label trial, which showed a successful clinical response among 86% of patients after seven days of treatment; the same for more than 90% of patients after 14 days.
Crucially, the former is the main endpoint used by the U.S. FDA.
Data from the Phase II trial has led investigators to surmise R327G a safe and efficacious treatment for DFI, particularly given that, through the use of a gel, patients can avoid having to use oral or IV antibiotics for the condition.
“This approval allows us to build upon the strong clinical results of R327G and continue demonstrating its potential as a differentiated treatment for DFIs,” Recce CEO James Grahama said today.
Mr Graham continued: “We are pleased to continue to provide access to R327G to diabetic patients in need, and to further build out our data portfolio alongside our Phase Three programs in both Australia and Indonesia.”
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Alongside this new study will be Recce’s Indonesian Phase Three trial on the gel, which will also provide data for future regulatory submissions.
RCE shares have been trading at 28.7 cents.
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