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Recce Pharmaceuticals Expands DFI Trial to Pivotal Phase 3
Recce Pharmaceuticals wins ethics approval to expand diabetic foot infection trial to Phase 3, adding moderate cases and below-knee ulcers. 18 of 200 patients enrolled; interim analysis at 50%.
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Recce Pharmaceuticals (ASX: RCE) has received Human Research Ethics Committee approval to shift its Australian study of RECCE 327 topical gel from Phase 2 into a pivotal Phase 3 trial for diabetic foot infections.
The protocol amendment adds moderate diabetic foot infection patients and allows the inclusion of infected ulcers below the knee, broadening the eligible recruitment pool significantly. Mild and moderate cases collectively represent roughly 80% of diabetic foot infection presentations, according to the company, which lifts the addressable population for the study.
The Australian program now runs alongside a separate Indonesian Phase 3 trial as part of a dual registration strategy targeting approvals in Australia, the US, the Middle East and North Africa, and Association of Southeast Asian Nations markets. Both trials are designed to meet Therapeutic Goods Administration and US Food and Drug Administration standards.
Recce has enrolled 18 of 200 planned patients so far. An interim analysis is scheduled once 50% of patients have completed treatment. The company targets full enrollment by the end of 2027, helped by the expanded criteria.