Beyond Antibiotics: Lakewood-Amedex Advances Diabetic Foot Ulcer Trial

Lakewood-Amedex Biotherapeutics Inc. (NASDAQ:LABT) on Thursday said it dosed the first patient in its Phase 2a clinical trial evaluating Nu-3 for mildly infected diabetic foot ulcers. The initiation of patient dosing represents a significant clinical milestone for Lakewood-Amedex Biotherapeutics as it accelerates the development of Nu-3. Lakewood-Amedex designed Nu-3 as a topically applied antimicrobial gel intended to rapidly eliminate harmful microbes directly at the site of infection. In addition, the topical formulation addresses critical limitations associated with conventional treatments, including the widespread challenge of antimicrobial resistance. Nu-3 Gel Trial Design And Antimicrobial Resistance Focus The Phase 2a trial evaluates Nu-3 across adult patients diagnosed with either Type 1 or Type 2 diabetes who present with mildly infected diabetic foot ulcers. Researchers are examining three distinct Nu-3 gel concentrations—2%, 5%, and 10%—to determine the overall safety and therapeutic efficacy of the candidate. Specifically, the study measures the gel’s ability to reduce microbial burden and successfully resolve active infection. Results from this Phase 2a study will directly inform dose selection for the company’s future clinical trials. Following completion of this study, Lakewood-Amedex plans to advance the research program into a Phase 2b study. The subsequent trial will compare different gel concentrations of Nu-3 administered as either once-a-day or twice-a-day treatments against a placebo. Topline data from the Phase 2a trial are expected in the first quarter of 2027. “As our lead clinical asset, Nu-3 represents a key value driver for the company, and this study is expected to deliver an important first clinical proof of concept to guide its development, while providing an opportunity to validate our differentiated Bisphosphocin platform,” said Thomas Balzer, Chief Medical Officer and Senior Vice President, Clinical Development of LABT. LABT Price Action: Lakewood-Amedex shares were down 3.93% at $1.81 at the time of publication on Thursday. The stock is trading near its 52-week low of $1.66, according to Benzinga Pro data. Read Also: Google’s Gemini 4 Could Launch 'Much Earlier’ Than Year-End, Says DeepMind Exec as AI Battle With OpenAI, Anthropic, Meta Heats up Image via Shutterstock