Lakewood-Amedex secures approvals to begin Phase 2a Nu-3 foot-ulcer trial

  • Lakewood-Amedex obtained approvals and site readiness for a Phase 2a Nu-3 trial.
  • Nu-3 will be evaluated in patients with mildly infected diabetic foot ulcers.
  • The trial builds on preclinical safety data and early exploratory findings, the company said.

Lakewood-Amedex Biotherapeutics has obtained central and all site Institutional Review Board (IRB) approvals and confirmed clinical trial site readiness for a Phase 2a study of Nu-3 in patients with mildly infected diabetic foot ulcers (iDFU). The topical gel is the company’s lead candidate from its Bisphosphocin class of fast-acting, broad-spectrum antimicrobials. The study will build on positive preclinical safety data and early exploratory results indicating that Nu-3 was well-tolerated and showed trends toward improved antimicrobial response and wound healing. Study Chair Dr. David G. Armstrong will guide the trial. The company said its development program is aligned with federal mandates from the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria and is intended to address drug-resistant wound infections. Lakewood-Amedex cautioned that its forward-looking statements involve risks involving trial execution, clinical outcomes, regulatory approval, manufacturing, supply and financing.

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