Full Press Release Details
Initiation of patient dosing marks significant clinical development milestone for Nu-3 and Lakewood-Amedex Biotherapeutics' proprietary Bisphosphocin ® antimicrobial platform
Topline data expected in the first quarter of 2027
SARASOTA, Fla., Sept. 24, 2026 /PRNewswire/ -- Lakewood-Amedex Biotherapeutics Inc., (NASDAQ: LABT, the "Company"), a clinical-stage biotechnology company advancing a novel class of potent, fast-acting, broad-spectrum antimicrobials for infectious diseases called the Bisphosphocin ® class, today announced that the first patient has been dosed in its Phase 2a clinical trial evaluating Nu-3 for the treatment of patients with mildly infected diabetic foot ulcers (iDFU).
The initiation of patient dosing represents a significant milestone for Lakewood-Amedex Biotherapeutics and the clinical advancement of Nu-3, a topically applied antimicrobial gel designed to rapidly eliminate microbes directly at the site of infection while addressing important limitations of conventional treatments, including antimicrobial resistance (AMR). The Phase 2a study is designed to evaluate the safety and efficacy of three concentrations of Nu-3 and inform dose selection for the Company's continued clinical development program. Topline data from the Phase 2a study are expected in the first quarter of 2027.
"Dosing the first patient in this Phase 2a trial represents a significant milestone for Lakewood-Amedex Biotherapeutics and the advancement of Nu-3 as a potential new treatment for infected diabetic foot ulcers," said Thomas Balzer, M.D., Ph.D., Chief Medical Officer and Senior Vice President, Clinical Development of Lakewood-Amedex Biotherapeutics. "As our lead clinical asset, Nu-3 represents a key value driver for the Company, and this study is expected to deliver an important first clinical proof of concept to guide its development, while providing an opportunity to validate our differentiated Bisphosphocin ® platform."
The Phase 2a trial is a multicenter, single-blinded, dose-finding study evaluating Nu-3 in adult patients with Type 1 or Type 2 diabetes and mildly infected diabetic foot ulcers. The study will evaluate three Nu-3 gel concentrations, 2%, 5%, and 10%, to assess safety and efficacy, including Nu-3's ability to reduce microbial burden and resolve infection. 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.
"Diabetic foot infections remain an enormous challenge for patients and clinicians, and we continue to need new approaches that can effectively control infection while supporting our broader goal of healing the wound and preserving the limb," said David G. Armstrong, DPM, M.D., Ph.D., Distinguished Professor of Surgery and Neurological Surgery at the Keck School of Medicine of USC and Study Chair for the Phase 2a trial. "Millions of people worldwide are affected by diabetic foot ulcers, yet treatment options for infected wounds remain limited, particularly as antimicrobial resistance makes these infections increasingly difficult to manage. Advancing a locally delivered topical antimicrobial such as Nu-3 through this study is an important opportunity to evaluate a differentiated approach that could ultimately expand the treatment options available to clinicians and patients."
The Phase 2a trial is being managed by Professional Education and Research Institute LLC (PERI), a contract research organization with expertise in wound care and podiatric clinical research. PERI is led by Charles Zelen, DPM, FACFAS, a practicing podiatrist with deep ties to the diabetic foot care community. 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.
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.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Lakewood-Amedex Biotherapeutics Inc.'s clinical development plans, regulatory strategy, anticipated trial timing, potential regulatory submissions or approvals, and the potential benefits, safety, efficacy and commercial potential of its Bisphosphocin ® platform and product candidates. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially, including risks that clinical trials may not be initiated, completed or successful on expected timelines or at all; preclinical or clinical results may not be predictive of future results; product candidates may not demonstrate safety or efficacy or receive regulatory approval; and risks related to manufacturing, supply, financing and other matters described in the company's SEC filings, including under "Risk Factors." Forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to update them except as required by law.