Lakewood-Amedex Advances Nu-3 Phase 2a Clinical Trial

Sarasota, Florida, September 18, 2026

Lakewood-Amedex Moves Nu-3 Into Phase 2a Development

The completion of IRB approvals and clinical-site readiness represents an important operational milestone for Lakewood-Amedex as it prepares to begin patient treatment in the Phase 2a study. The company said the trial will evaluate Nu-3 in people with mildly infected diabetic foot ulcers, a patient population that can face substantial risks from persistent infection, delayed wound healing and progression to more serious complications. According to the company, the study is intended to assess both the safety and efficacy of the investigational treatment as clinical development progresses.

Diabetic foot ulcers are a significant healthcare challenge, particularly when infection develops and treatment becomes more difficult. Lakewood-Amedex noted that infected diabetic foot ulcers affect millions of people globally and remain associated with serious consequences, including an increased risk of lower-limb amputation. The company is therefore pursuing Nu-3 as a potential locally delivered antimicrobial approach for wound infections where new treatment options may be needed. The company said the Phase 2a program builds on positive preclinical safety data and early exploratory findings. Those earlier studies indicated that Nu-3 was well tolerated and showed trends toward improved antimicrobial response and wound healing. However, these earlier findings are not a substitute for controlled clinical evidence, and the Phase 2a trial is expected to provide additional information about the candidate’s safety and therapeutic activity in patients.

Nu-3 Targets Drug-Resistant Wound Infections

Nu-3 is a proprietary topical gel based on Lakewood-Amedex’s Bisphosphocin® technology. According to the company, the candidate uses a distinctive mechanism of action that destabilizes microbial cell membranes. Lakewood-Amedex believes this mechanism may create a high barrier to the development of antimicrobial resistance, an important consideration as healthcare providers continue to confront bacterial infections that are increasingly difficult to treat with existing antimicrobial therapies.

The company is developing its Bisphosphocin® platform as a class of fast-acting, broad-spectrum antimicrobials intended to address infectious diseases and resistant bacterial strains. Its development strategy includes targeting pathogens such as MRSA and VRE, among other bacterial threats. The focus on resistance-evading antimicrobial mechanisms places Nu-3 within a broader pharmaceutical research effort to develop new approaches against infections where conventional antibiotics may have limitations.

Phase 2a Study Marks Key Clinical Development Step

With all required IRB approvals obtained and clinical sites prepared, Lakewood-Amedex is positioned to begin the Phase 2a clinical evaluation of Nu-3. The company said the program supports its broader strategy of developing new antimicrobial treatments for drug-resistant infections and aligns with federal efforts addressing antibiotic resistance. The company’s Chief Medical Officer, Thomas Balzer, M.D., Ph.D., highlighted the potential importance of developing new therapies for infected diabetic foot ulcers and identified internationally recognized diabetic-foot expert David G. Armstrong as Study Chair. The upcoming clinical study will be an important test of whether the encouraging observations from earlier research can translate into meaningful clinical outcomes in patients with infected diabetic foot ulcers. Safety, efficacy, antimicrobial activity and wound-healing outcomes will be important considerations as Nu-3 advances through clinical development.

For Lakewood-Amedex Biotherapeutics, the transition into Phase 2a represents a significant step in the development of its Bisphosphocin® antimicrobial platform. If the clinical program produces supportive results, the data could help guide subsequent development and regulatory planning for Nu-3. At this stage, however, the candidate remains investigational, and its safety and efficacy in treating infected diabetic foot ulcers remain subjects of clinical evaluation.

Source: Lakewood-Amedex Biotherapeutics press release