Lakewood-Amedex Doses First Patient in Phase 2a Trial of Nu-3 Gel for Infected Diabetic Foot Ulcers
核心洞察
Lakewood-Amedex Biotherapeutics (搜索) has dosed the first patient in a Phase 2a trial of its topical antimicrobial gel Nu-3 in mildly infected diabetic foot ulcers (搜索).
The multicenter, single-blinded, dose-finding study will test three Nu-3 gel concentrations, 2%, 5% and 10%, to assess safety and efficacy.
Topline data are expected in the first quarter of 2027, with the program then expected to advance to a placebo-controlled Phase 2b study.
Lakewood-Amedex Biotherapeutics (搜索) Inc. has dosed the first patient in its Phase 2a clinical trial of Nu-3, a topically applied antimicrobial gel, in adults with mildly infected diabetic foot ulcers (搜索) (iDFU). The company announced the milestone on Sept. 24, 2026, describing it as a significant step in the clinical advancement of Nu-3 and its proprietary Bisphosphocin antimicrobial platform.
The Phase 2a study is a multicenter, single-blinded, dose-finding trial enrolling adult patients with Type 1 or Type 2 diabetes (搜索) and mildly infected diabetic foot ulcers (搜索). It will evaluate three Nu-3 gel concentrations, 2%, 5% and 10%, to assess safety and efficacy, including the agent's ability to reduce microbial burden and resolve infection. The results are intended to inform dose selection for the company's continued clinical development program. Topline data are expected in the first quarter of 2027.
Nu-3 is designed to rapidly eliminate microbes directly at the site of infection while addressing important limitations of conventional treatments, including antimicrobial resistance (AMR). It is the company's lead clinical asset.
"Dosing the first patient in this Phase 2a trial represents a significant milestone for Lakewood-Amedex Biotherapeutics (搜索) and the advancement of Nu-3 as a potential new treatment for infected diabetic foot ulcers (搜索)," 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."
Development Path After Phase 2a
Following completion of the Phase 2a study, the program is expected to advance to a Phase 2b trial evaluating different gel concentrations of Nu-3 as either once-a-day or twice-a-day treatments in comparison to placebo.
Clinical Need in Diabetic Foot Infection
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, framed the study against the limited options available for infected wounds.
"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," Armstrong said. "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."
Trial Execution
The Phase 2a trial is being managed by Professional Education and Research Institute (搜索) 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 ties to the diabetic foot care community. According to the company, PERI's established network of investigators and access to relevant clinical sites is expected to support efficient patient recruitment and high-quality data generation.
Lakewood-Amedex Biotherapeutics (搜索) is a clinical-stage biotechnology company developing the Bisphosphocin class of fast-acting, broad-spectrum antimicrobials to treat infectious diseases and reduce the threat posed by antibiotic-resistant bacterial strains, including MRSA (搜索) and VRE (搜索).