RECCE 435 (R435)
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Recce Pharmaceuticals Receives Approval for Additional Phase II Trial of RECCE® 327 Topical Gel for Diabetic Foot Infections
Globenewswire· 2025-04-23 12:00
Core Insights - Recce Pharmaceuticals has received Human Research Ethics Committee (HREC) approval to expand its open-label Phase II trial of RECCE 327 Topical Gel (R327G) for diabetic foot infections (DFI), allowing the enrollment of up to 20 additional patients [1][8] Company Developments - The approval enables Recce to build on the strong clinical results of R327G, which showed an 86% successful clinical response after 7 days of treatment and over 90% at 14 days [2][8] - The trial investigators have expressed confidence in R327G as a safe and well-tolerated option for difficult-to-treat infections, avoiding systemic antibiotics and their adverse effects [3][5] - The study will run in parallel with ongoing Phase 3 trials in Indonesia and Australia, aimed at generating additional data for future regulatory submissions [4][8] Market Context - The recurrence rate of DFI is significant, with 40% within one year, 60% within three years, and 65% within five years, highlighting the urgent need for effective treatments [5] - The World Health Organization has recognized Recce's products as part of the clinical development pipeline for priority pathogens, addressing the global challenge of antibiotic resistance [10]