The multicenter, single-blinded study tests three concentrations of the topical gel—2%, 5%, and 10%—to determine the optimal dosage for future clinical development. By targeting microbial burdens directly at the wound site, Nu-3 is designed to circumvent the limitations of conventional antibiotics and address the growing threat of antimicrobial resistance. The company expects to release topline data from this trial in the first quarter of 2027.
Lakewood-Amedex Begins Phase 2a Trial for Diabetic Foot Ulcer Treatment
Lakewood-Amedex Biotherapeutics has administered the first dose of its experimental antimicrobial gel, Nu-3, to a patient in a Phase 2a clinical trial. The study aims to evaluate the treatment’s safety and efficacy in managing mildly infected diabetic foot ulcers, marking a pivotal step for the company’s proprietary Bisphosphocin platform.
Dr. David G. Armstrong, the study chair and a professor at the Keck School of Medicine of USC, emphasized that the trial addresses a critical gap in wound care. As antimicrobial resistance renders standard infections increasingly difficult to manage, local delivery systems like Nu-3 offer a potential alternative to preserve limbs and improve patient outcomes. The trial is being managed by the Professional Education and Research Institute, which will oversee patient recruitment across a network of clinical sites.
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