Lakewood-Amedex Biotherapeutics Selects Specialist CRO PERI to Lead Phase 2 Trial of Nu-3 in Diabetic Foot Ulcers

• Lakewood-Amedex Biotherapeutics (NASDAQ: LABT) has appointed Professional Education and Research Institute LLC (PERI) as the CRO for its upcoming Phase 2 clinical program of Nu-3, its lead Bisphosphocin antimicrobial candidate for the treatment of mildly infected diabetic foot ulcers (iDFU).

• PERI was selected for its specialized track record in wound care and podiatric medicine, established investigator site network, and clinical expertise in managing trials within the iDFU patient population — positioning the program for efficient patient recruitment and quality data generation toward a potential registration pathway.

Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) has entered into an agreement with Professional Education and Research Institute LLC (PERI) to serve as the CRO for its Phase 2 clinical program of Nu-3, the company’s lead antimicrobial candidate for the treatment of mildly infected diabetic foot ulcers (iDFU). The announcement was made on May 12, 2026, from Sarasota, Florida.

Nu-3 belongs to the Bisphosphocin class of antimicrobials, a novel therapeutic category characterized by a unique mechanism of action that enables rapid elimination of a broad spectrum of bacteria — including antibiotic-resistant pathogens and biofilms. The Phase 2 program will begin with a single-blinded Phase 2a study comparing 2%, 5%, and 10% gel concentrations, followed by a Phase 2b study evaluating different gel concentrations as either once-daily or twice-daily treatments compared to placebo.

The selection of PERI as CRO reflects a deliberate therapeutic-area alignment rather than a generalist outsourcing decision. PERI was founded by Charles Zelen, DPM, FACFAS, a practicing podiatrist with established relationships across the diabetic foot care clinical community. The organization brings operational expertise in iDFU study management, an established investigator site network, and direct access to the relevant patient population — all factors the company has identified as critical to supporting efficient recruitment and high-quality data generation toward a potential registration pathway.

Infected diabetic foot ulcers represent a significant and growing unmet medical need. The condition affects millions of patients globally and, when not controlled at an early stage, frequently leads to hospitalization and amputation. The rise of antibiotic-resistant pathogens has further complicated treatment options for clinicians and sponsors alike, increasing the urgency for novel therapeutic approaches with differentiated mechanisms such as those offered by the Bisphosphocin® class.

“Advancing Nu-3 into a Phase 2 clinical trial represents a critical step forward in our mission to address the growing global challenge of antibiotic-resistant infections.”

Thomas Balzer, M.D., Ph.D., Chief Medical Officer, Lakewood-Amedex Biotherapeutics