Recce Pharmaceuticals Ltd. is set to commence a pivotal Phase 3 clinical trial in Indonesia, evaluating the efficacy of RECCE 327 topical gel in treating diabetic foot infections. This development is a significant step forward in addressing a critical unmet need for effective therapies in this patient population.
The trial, backed by both the Australian and Indonesian governments, aims to assess the safety and efficacy of RECCE 327 in patients with diabetic foot infections. If successful, the market launch is anticipated in 2026, potentially opening doors to broader markets in the Asia Pacific region.
Diabetic foot infections represent a significant global health challenge, often leading to hospitalization, amputation, and increased mortality. Current treatment options, including systemic antibiotics and surgical debridement, can be limited by antibiotic resistance, poor tissue perfusion, and other factors.
RECCE 327 is a synthetic polymer antibiotic designed to combat a broad spectrum of bacteria, including multi-drug resistant strains. Its unique mechanism of action involves disrupting bacterial cell walls, potentially minimizing the risk of resistance development.
The Phase 3 trial will enroll patients with clinically diagnosed diabetic foot infections. The primary endpoint will likely focus on clinical cure rates and infection resolution. Secondary endpoints may include time to healing, reduction in wound size, and safety assessments.
"This Phase 3 trial is a crucial step in bringing RECCE 327 to patients who desperately need new treatment options for diabetic foot infections," said a spokesperson for Recce Pharmaceuticals. "We are committed to developing innovative solutions to combat antimicrobial resistance and improve patient outcomes."
Success in this trial would not only provide a new therapeutic option for diabetic foot infections but also validate Recce Pharmaceuticals' technology platform and its potential to address other infectious diseases.
