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Lakewood-Amedex Prepares Phase 2a Trial for Nu-3 Diabetic Foot Gel

Lakewood-Amedex Prepares Phase 2a Trial for Nu-3 Diabetic Foot Gel

Sarasota-based Lakewood-Amedex Biotherapeutics has cleared a critical regulatory hurdle, reporting positive preclinical safety data for its Nu-3 gel. The findings confirm that the Bisphosphocin-based treatment is well-tolerated at high doses, setting the stage for imminent Phase 2a clinical trials targeting infected diabetic foot ulcers.

The company’s safety study demonstrated that Nu-3 gel maintains localized therapeutic impact with minimal systemic exposure, significantly reducing the risk of side effects. Crucially, the formulation showed no inhibition of natural wound-healing processes, an essential requirement for treating complex diabetic ulcers. These results provide the technical foundation for the planned Phase 2a evaluation, which will test 2%, 5%, and 10% gel concentrations.

Chief Executive Officer Kelvin Cooper noted that the study’s findings bolster confidence in the therapeutic index of the drug as the firm moves toward patient trials. Chief Medical Officer Thomas Balzer added that the compound’s ability to tackle highly resistant bacterial strains and complex biofilms makes it a candidate for patients struggling with chronic infections. Lakewood-Amedex continues to leverage its proprietary Bisphosphocin class to address global antimicrobial resistance, with the upcoming study aimed at confirming both the efficacy and safety profile of the topical treatment in human subjects.

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