SARASOTA, Fla., July 15, 2026
Lakewood-Amedex Biotherapeutics Inc. has announced encouraging preclinical safety results supporting dose selection for the upcoming Phase 2a clinical trial of Nu-3 Gel, an investigational topical antimicrobial therapy designed to treat infected diabetic foot ulcers (iDFUs). The latest findings provide a significant milestone in the company’s clinical development program by demonstrating that Nu-3 was well tolerated in FDA-required safety studies while showing minimal systemic exposure, reinforcing its potential as a localized treatment with a low likelihood of systemic side effects. Built on the company’s proprietary Bisphosphocin® antimicrobial platform, Nu-3 is being developed to address one of the most pressing healthcare challenges—the treatment of difficult bacterial infections associated with diabetic foot ulcers, including infections caused by antibiotic-resistant pathogens. With antimicrobial resistance continuing to threaten healthcare systems worldwide, innovative therapies capable of rapidly eliminating pathogens while minimizing toxicity remain a major focus of pharmaceutical research. The newly reported safety data strengthens confidence in the planned Phase 2a study and represents another important step toward developing a novel treatment option for patients with chronic wound infections.
Preclinical Safety Data Supports Phase 2a Dose Selection
The FDA-required preclinical safety study evaluated Nu-3 Gel at dose levels substantially higher than those planned for clinical testing, providing strong evidence supporting the product’s safety profile. According to Lakewood-Amedex Biotherapeutics, the investigational therapy was well tolerated, produced very low systemic exposure, and importantly did not interfere with normal wound healing, an essential consideration for therapies intended to treat diabetic foot ulcers. Based on the combined evidence generated from in vitro antimicrobial testing, animal wound infection models, and the recently completed safety evaluation, the company has selected 2%, 5%, and 10% gel formulations for investigation in the upcoming Phase 2a clinical trial. These dose levels are expected to provide comprehensive information regarding antimicrobial effectiveness, dose response, patient safety, and treatment tolerability. The encouraging findings also support the therapeutic potential of Nu-3 as a localized topical therapy capable of delivering high antimicrobial activity directly at the infection site while limiting systemic drug exposure.
Bisphosphocin Platform Targets Resistant Bacterial Infections
Nu-3 represents one of the lead clinical candidates developed from Lakewood-Amedex Biotherapeutics’ Bisphosphocin® platform, a proprietary class of fast-acting, broad-spectrum antimicrobial compounds designed to combat serious infectious diseases, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and other multidrug-resistant bacterial strains. Company leadership emphasized that the latest preclinical findings provide growing confidence as preparations continue for the initiation of the Phase 2a study. Chief Executive Officer Dr. Kelvin Cooper noted that the safety profile demonstrates the potential for Nu-3 to become a safe and effective topical antimicrobial with an encouraging therapeutic index.
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Meanwhile, Chief Medical Officer Dr. Thomas Balzer highlighted that Nu-3’s combination of broad-spectrum antimicrobial activity, rapid bacterial killing, effectiveness against complex bacterial biofilms, and low systemic absorption could position the therapy as a differentiated treatment option for infected diabetic foot ulcers. Chronic diabetic foot infections remain a major cause of hospitalization, lower-limb amputations, and increased healthcare costs worldwide, creating substantial demand for innovative therapies capable of improving wound healing outcomes while reducing antibiotic resistance. As Lakewood-Amedex Biotherapeutics advances toward Phase 2a clinical evaluation, the company’s latest safety data reinforces the scientific potential of the Bisphosphocin® platform to deliver a new generation of targeted antimicrobial therapies addressing critical unmet medical needs in infectious disease management.
Source: Lakewood-Amedex Biotherapeutics press release
