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Lakewood-Amedex Biotherapeutics Announces IRB Approval and Clinical Site Readiness to Initiate Phase 2a Clinical Trial of Nu-3 for the Treatment of Infected Diabetic Foot Ulcers

  • Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) obtained central & all site Institutional Review Board approvals to commence its Phase 2a clinical trial.
  • The trial will evaluate the safety & efficacy of the lead product candidate Nu-3 in patients with mildly infected diabetic foot ulcers (iDFU).
  • The study is led by Study Chair Dr. David G. Armstrong & aims to address drug-resistant wound infections.
  • Nu-3 is a proprietary topical gel formulation using a unique mechanism to destabilize microbial cell membranes & offer a high barrier against antimicrobial resistance.
  • Previous preclinical data & early exploratory results showed Nu-3 was well-tolerated with trends of improved antimicrobial response & wound healing.
  • The development aligns with federal mandates from the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB).