Specialized CRO partnership supports Phase 2 program to advance Nu-3 toward potential registration pathway in large, underserved iDFU market
SARASOTA, Fla., May 12, 2026 /PRNewswire/ -- Lakewood-Amedex Biotherapeutics Inc., (NASDAQ: LABT), a clinical-stage biotechnology company advancing a novel class of potent, fast-acting, broad-spectrum antimicrobials for locally treatable infectious diseases called the Bisphosphocin® class, today announced that it has entered into an agreement with Professional Education and Research Institute LLC (PERI) to serve as the contract research organization (CRO) for its upcoming Phase 2 clinical program of Nu-3, the Company's lead Bisphosphocin® product for the treatment of mildly infected diabetic foot ulcers (iDFU). Nu-3 belongs to a novel class of antimicrobials (Bisphosphocin®) possessing a unique mechanism of action that enables rapid elimination of a broad spectrum of bacteria, including resistant pathogens and biofilms, based on available non-clinical in vitro and in vivo data.
The selection of PERI reflects strategic alignment with a CRO that has a strong track record in wound care and podiatric medicine. Founded by Charles Zelen, DPM, FACFAS, a practicing podiatrist with deep ties to the diabetic foot care community, PERI brings a unique combination of clinical insight, investigator relationships, and operational expertise in managing studies within this patient population. The organization's established network of investigators and access to relevant clinical sites is expected to support efficient patient recruitment and high-quality data generation.
"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," said Thomas Balzer, M.D., Ph.D., Chief Medical Officer of Lakewood-Amedex Biotherapeutics. "We are pleased to partner with PERI, whose deep expertise in wound care and diabetic foot ulcers, combined with strong clinical execution capabilities, makes them an ideal collaborator for this important study."
The planned Phase 2 program is designed to evaluate the safety and efficacy of Nu-3 in patients with iDFU, a serious and prevalent complication of diabetes that is associated with high morbidity, risk of amputation, and significant healthcare costs. The program will begin with a single-blinded Phase 2a study comparing 2%, 5% and 10% gel concentrations to establish initial proof of concept in humans. Following this, the program is expected to advance to a Phase 2b study, evaluating different gel-concentrations of Nu-3 as either once-a-day or twice-a-day treatments in comparison to placebo.
"We are excited to collaborate with Lakewood-Amedex on the advancement of Nu-3," said Dr. Zelen. "As a clinician treating patients with diabetic foot ulcers, I recognize the urgent need for new, effective and local therapies that can control infection and assist healing of the wound. Nu-3's novel mechanism and targeted approach have the potential to make a meaningful impact for patients and providers."
Infected diabetic foot ulcers represent a significant unmet medical need, affecting millions of patients worldwide and often leading to hospitalization and amputation if the infection cannot be controlled in an early stage. The emergence of antibiotic-resistant pathogens has further complicated treatment, underscoring the need for innovative therapeutic options such as Nu-3.
About Lakewood-Amedex Biotherapeutics Inc.
Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) is a clinical-stage biotechnology company developing a novel class of fast-acting, broad-spectrum antimicrobials - the Bisphosphocin ® class - to treat infectious diseases and reduce the threat posed by antibiotic-resistant bacterial strains, including MRSA, VRE, and others. For more information, please visit https://lakewoodamedex.com.
About PERI
Professional Education and Research Institute LLC (PERI) is a midsize contract research organization specializing in the design and execution of clinical trials in wound care and podiatry, among other therapeutic areas. The company leverages deep clinical expertise, strong investigator relationships, and a focused operational model to deliver high-quality clinical research services. PERI was founded by Charles Zelen, DPM, FACFAS, an active practicing podiatrist with extensive experience in the treatment of diabetic foot ulcers.
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SOURCE Lakewood-Amedex Biotherapeutics Inc.
