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Lakewood-Amedex Biotherapeutics Highlights Safety of Nu-3 Gel

In an exciting development for the biopharmaceutical industry, Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) recently shared promising preclinical safety data for its innovative Nu-3 gel formulation. Designed for the treatment of infected diabetic foot ulcers, this topical solution is part of a unique class of antimicrobials known as Bisphosphocins®. As Lakewood-Amedex prepares for its Phase 2a clinical trial, the data not only supports the gel's potential effectiveness but also addresses safety concerns, a crucial aspect in clinical applications.

Breakthrough Safety Data

The announcement, made on July 15, 2026, underscores Nu-3's excellent safety profile as indicated by results from a recent FDA-required safety study. These findings are particularly noteworthy as they demonstrate that the gel formulation was well tolerated by participants, with no adverse effects on wound healing. Kelvin Cooper, Ph.D., the Chief Executive Officer of Lakewood-Amedex, expressed optimism regarding the results, emphasizing their significance in establishing a strong foundation for the upcoming clinical trial.

The study involved administering doses that far exceeded those intended for the forthcoming Phase 2a trial, which revealed very low levels of systemic exposure. This outcome is encouraging as it suggests minimal risk of systemic side effects, ensuring that the treatment can be focused and effective at the site of application.

Phase 2a Clinical Trial Preparation

Lakewood-Amedex is currently finalizing preparations for its upcoming clinical trial aimed at assessing the effectiveness of Nu-3 in treating infected diabetic foot ulcers (iDFU). The clinical study will evaluate various concentrations of the gel, specifically at 2%, 5%, and 10%. The data supporting these doses stems from in vitro antimicrobial activity, in vivo testing in animal models, and the recent positive safety study results, all of which enhance confidence in the gel's anticipated therapeutic benefits.

Dr. Thomas Balzer, M.D., Ph.D., Chief Medical Officer, articulated the unique advantages of Nu-3, stating that it offers not only fast-acting antimicrobial activity but also efficacy against resistant strains of bacteria and complex biofilms. He highlighted that these characteristics make it an ideal candidate for managing the challenges posed by hard-to-treat infected diabetic foot ulcers.

The Importance of Targeted Treatments

Infectious diseases, especially those resulting from diabetic foot ulcers, pose significant health challenges, including prolonged healing times and increased risk of amputations. Traditional antibiotics often fail to adequately address these infections due to rising antibiotic resistance. Lakewood-Amedex’s focus on developing a targeted antimicrobial solution through Nu-3 places it at the forefront of addressing this growing public health concern. The therapeutic strategy aims to not only provide immediate benefits through localized treatment but also contribute to the broader fight against antibiotic resistance.

Moving Forward

As Lakewood-Amedex marches towards the initiation of its Phase 2a study, the preclinical safety data provides a source of optimism for patients and healthcare providers alike. With strong foundations laid through scientific research and safety assessments, there is great hope that Nu-3 will emerge as a safe and effective treatment option for those suffering from infected diabetic foot ulcers. The company’s commitment to advancing its innovative Biophosphocin® technologies indicates a bright future in improving patient outcomes in infectious disease management.

For more information on Lakewood-Amedex Biotherapeutics Inc., visit https//lakewoodamedex.com.