Lakewood-Amedex doses first patient in Nu-3 diabetic ulcer trial

SARASOTA, Fla. - Lakewood-Amedex Biotherapeutics Inc. announced the dosing of the first patient in a Phase 2a clinical trial for Nu-3, a topical antimicrobial gel designed to treat diabetic foot ulcers. The study will assess three concentrations of Nu-3 gel - 2%, 5%, and 10% - on adult patients with Type 1 or Type 2 diabetes and mildly infected foot ulcers.

The trial aims to evaluate safety, efficacy, and the treatment's ability to reduce microbial burden and resolve infection. The company anticipates releasing top-line data from the Phase 2a study in Q1 2027. Upon successful completion, the program will progress to a Phase 2b study, comparing Nu-3's effectiveness in once-a-day or twice-a-day treatments against placebo.

Nu-3 is part of Lakewood-Amedex's Bisphosphocin antimicrobial platform, which the company is developing for infectious diseases. Thomas Balzer, Lakewood-Amedex's Chief Medical Officer and Senior Vice President of Clinical Development, emphasized the significance of this milestone in advancing Nu-3 as a potential new treatment for infected diabetic foot ulcers.

The trial is being managed by Professional Education and Research Institute LLC, led by podiatrist Charles Zelen. Lakewood-Amedex is a clinical-stage biotechnology company focused on developing antimicrobials to combat infectious diseases and antibiotic-resistant bacterial strains.