Lakewood-Amedex Biotherapeutics Announces IRB Approval and Clinical Site Readiness to Initiate Phase 2a Clinical Trial of Nu-3 for the Treatment of Infected Diabetic Foot Ulcers

SARASOTA, Fla., Sept. 18, 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 it has obtained central and all site Institutional Review Board (IRB) approvals and confirmed clinical trial site readiness to commence its Phase 2a clinical trial evaluating the safety and efficacy of its lead product candidate, Nu-3, in patients with mildly infected diabetic foot ulcers (iDFU).

"Together, these milestones mark another significant step forward in the company's clinical development strategy to address the urgent medical need for new treatments for drug-resistant wound infections," said Thomas Balzer, M.D., Ph.D., Chief Medical Officer of Lakewood-Amedex Biotherapeutics. "With the guidance of our Study Chair, the world-renowned expert Dr. David G. Armstrong, we are well-positioned to evaluate 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."

The Phase 2a trial is designed to 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. 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) by providing innovative, resistance-evading therapies. Nu-3, a proprietary topical gel formulation, utilizes a unique mechanism of action that destabilizes microbial cell membranes, offering a high barrier for bacteria to the development of antimicrobial resistance (AMR) against it.

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.

Contact

Investor Relations 
Tiberend Strategic Advisors, Inc.
David Irish
(231) 632-0002  
[email protected] 

Media Relations 
Tiberend Strategic Advisors, Inc.
Casey McDonald
(646) 577-8520 
[email protected] 

SOURCE Lakewood-Amedex Biotherapeutics Inc.