Lakewood-Amedex Biotherapeutics Sets Stage for Phase 2a Clinical Trial of Nu-3

SARASOTA, Fla., Sept. 18, 2026 /CourierPR/ -- Lakewood-Amedex Biotherapeutics Inc. has achieved a significant milestone in its clinical development strategy by obtaining Institutional Review Board (IRB) approvals and confirming clinical trial site readiness for its Phase 2a clinical trial. The trial will evaluate the safety and efficacy of Nu-3, the company’s lead product candidate, in patients with mildly infected diabetic foot ulcers (iDFU).

The company’s Chief Medical Officer, Dr. Thomas Balzer, expressed optimism about the upcoming trial. The trial will build upon positive preclinical safety data and early exploratory results, which demonstrated that Nu-3 was well-tolerated and showed trends of improved antimicrobial response and wound healing.

Nu-3 is a proprietary topical gel formulation that utilizes a unique mechanism of action to destabilize microbial cell membranes. This mechanism offers a high barrier for bacteria to develop antimicrobial resistance (AMR) against the product. The company remains committed to aligning its development efforts with the federal mandates set forth by the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB).

The Phase 2a trial is designed to further validate the safety and efficacy of Nu-3 in patients with iDFU. Dr. David G. Armstrong, a world-renowned expert and the company’s Study Chair, will guide the trial. Armstrong's expertise will be crucial in evaluating how Nu-3 can potentially improve patient outcomes in the management of iDFU, a condition that impacts millions of lives worldwide and remains a leading cause of lower-limb amputations.

Lakewood-Amedex Biotherapeutics Inc. 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. The company’s commitment to innovation and addressing urgent medical needs is evident in its ongoing clinical trials and development efforts.

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.