Recce Pharmaceuticals Ltd has received ethics approval to proceed with its Phase 3 clinical trial of RECCE® 327 in Indonesia. This trial aims to assess the safety and efficacy of RECCE® 327 for the treatment of infected diabetic foot ulcers, a significant and growing global health concern.
Trial Design and Objectives
The Phase 3 trial is designed as a randomized, double-blind, placebo-controlled study. Patients with infected diabetic foot ulcers will be enrolled and randomized to receive either RECCE® 327 or a placebo, in addition to standard wound care. The primary endpoint of the trial is the proportion of patients achieving complete wound closure at a specified time point. Secondary endpoints include measures of infection resolution, reduction in wound size, and safety assessments.
RECCE® 327: A Novel Anti-Infective
RECCE® 327 is a synthetic polymer anti-infective agent with a broad spectrum of antibacterial activity. It has demonstrated efficacy against both Gram-positive and Gram-negative bacteria, including multidrug-resistant strains. Its unique mechanism of action involves disrupting bacterial cell walls, leading to cell death. This mechanism differs from that of traditional antibiotics, potentially reducing the risk of resistance development.
Clinical Significance
Infected diabetic foot ulcers represent a major challenge in healthcare, often leading to significant morbidity, amputation, and increased healthcare costs. The current treatment options are limited, and the emergence of antibiotic-resistant bacteria further complicates management. RECCE® 327 offers a potential new approach to treating these infections, addressing an unmet medical need.
Regulatory Pathway
The successful completion of this Phase 3 trial is a critical step towards regulatory approval and commercialization of RECCE® 327. Positive results would support registration filings with regulatory agencies, potentially leading to a new treatment option for patients with infected diabetic foot ulcers.
