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Lakewood-Amedex Biotherapeutics Announces Agreement with PERI to Serve as CRO for Phase 2 Clinical Trial of Nu-3

LABT
  • Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) has appointed Professional Education and Research Institute LLC (PERI) as the contract research organization for its upcoming Phase 2 clinical program of Nu-3.
  • The Phase 2 program aims to advance Nu-3, a novel Bisphosphocin antimicrobial, toward a potential registration pathway for treating mildly infected diabetic foot ulcers (iDFU).
  • Nu-3 utilizes a unique mechanism of action to rapidly eliminate broad-spectrum bacteria, including resistant pathogens & biofilms, based on non-clinical data.
  • PERI was selected for its strong track record in wound care & podiatric medicine, founded by Charles Zelen, DPM, FACFAS, a practicing podiatrist with deep ties to the diabetic foot care community.
  • The Phase 2a study will be single-blinded to compare 2%, 5%, & 10% gel concentrations to establish initial proof of concept in humans.
  • The subsequent Phase 2b study is expected to evaluate different gel concentrations as once-a-day or twice-a-day treatments compared to a placebo.
  • The initiative addresses the unmet medical need for effective local therapies for iDFU, a condition associated with high morbidity, amputation risks, & antibiotic-resistant infections.
  • Thomas Balzer, M.D., Ph.D., Chief Medical Officer of Lakewood-Amedex, highlighted the strategic alignment with PERI's clinical execution capabilities.
  • Investor & media contact details are provided by Tiberend Strategic Advisors, Inc., including David Irish for investor relations & Casey McDonald for media relations.