Proactive - Interviews for investors

Lakewood-Amedex doses first patient in Phase 2a trial for Diabetic foot infections

Episode Summary

Lakewood-Amedex Biotherapeutics CEO Kelvin Cooper joined Steve Darling from Proactive to announce a significant clinical milestone for the company, confirming that the first patient has been dosed in its Phase 2a clinical trial evaluating Nu-3 for the treatment of mildly infected diabetic foot ulcers. Cooper said the initiation of patient dosing marks an important step forward in the development of Nu-3, a topically applied antimicrobial gel that forms part of the company's proprietary Bisphosphocin® platform. The technology is designed to rapidly eliminate microbes directly at the site of infection while addressing one of the most pressing challenges in healthcare today—antimicrobial resistance (AMR). According to Cooper, Nu-3 has been developed as a fast-acting, broad-spectrum antimicrobial treatment that could provide a targeted alternative to conventional therapies by reducing microbial burden locally without relying on traditional systemic antibiotics. The Phase 2a study is designed to evaluate both the safety and efficacy of Nu-3 while helping determine the optimal dose for future clinical development. The multicenter, single-blinded, dose-finding trial is enrolling adult patients with either Type 1 or Type 2 diabetes who are suffering from mildly infected diabetic foot ulcers, a common and often difficult-to-treat complication of diabetes. Researchers will assess three different concentrations of the Nu-3 gel—2%, 5%, and 10%—to evaluate their ability to reduce infection and improve patient outcomes. The study will examine key endpoints related to safety, infection resolution, and reductions in microbial burden within the ulcer. Cooper noted that diabetic foot infections remain a significant healthcare challenge globally, often leading to prolonged treatment, hospitalization, and, in severe cases, amputation. The company believes Nu-3's localized antimicrobial approach may offer an important new option for patients while helping reduce reliance on conventional antibiotics. Topline results from the Phase 2a study are expected during the first quarter of 2027. If successful, Lakewood-Amedex plans to advance the program into a Phase 2b clinical trial. Cooper said the first patient dosing represents more than just the start of a clinical study—it is an important validation of the company's broader Bisphosphocin® antimicrobial platform and its potential role in addressing infectious diseases in an era of increasing antibiotic resistance. #proactiveinvestors #lakewood-amedex #nasdaq #labt #KelvinCooper #Biotech #AntimicrobialResistance #AMR #ClinicalTrials #Phase2 #DiabeticFootUlcers #InfectiousDiseases #DrugDevelopment #Biotechnology #Healthcare #MedicalResearch