Lakewood-Amedex Biotherapeutics Announces Positive Data Against Recent Clinical Isolates from Infected Diabetic Foot Ulcers

Lead candidate Nu-3 is a topically formulated Bisphosphocin®, designed to rapidly kill microbes while reducing the risk of antimicrobial resistance

SARASOTA, FL - 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, announced positive Minimum Inhibitory Concentration (MIC) data from recent clinical isolates for its lead clinical candidate, Nu-3. Nu-3 is currently being investigated in a Phase 2a clinical trial as a topical treatment of mildly infected diabetic foot ulcers (iDFU) with topline data expected in the first quarter of 2027.

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MIC testing analysis of Nu-3 assessed in vitro activity against recent clinical isolates (collected within the last 3 years) from infected diabetic foot ulcers. Lakewood-Amedex Biotherapeutics evaluated the bactericidal activity of Nu-3 against several resistant pathogens, including resistant and susceptible Staphylococcus aureus (MRSA and MSSA respectively) and resistant and susceptible Enterococcus faecalis (VRE and VSE respectively). The clinical isolates utilized in the study were collected across 14 medical centers in the U.S. from patients suffering from diabetic foot infections.

"The positive MIC data in clinical isolates are another encouraging signal supporting continued study of Nu-3 and the Bisphosphocin class," said Kelvin Cooper, Ph.D., Chief Executive Officer of Lakewood-Amedex Biotherapeutics. "Importantly, the data show clear and positive cidal activity against specific microbes isolated from real world patients. These microbes are a clear threat to patients with iDFU, and more broadly represent the global threat of antibiotic resistance."

In the study, Nu-3 demonstrated consistent activity against all organisms, which were within the range of previous assay results conducted with 285 clinical isolates covering 15 varied species. Notably, indicating a favorable dosing margin and a strong therapeutic window, the MIC values were 2-8 times lower than the planned doses for clinical trials. Antibacterial activity of Nu-3 was not affected by the drug resistance phenotype. S. aureus (ATCC 29213) and E. faecalis (ATCC 29212) were used as control strains.

iDFUs represent a significant unmet medical need, affecting millions of patients worldwide and often leading to hospitalization and amputation if the infection cannot be controlled in early stages. Of the 830 million people in the world with diabetes, about one third will develop a DFU. Close to 50% of DFUs become infected, and 15-20% of iDFUs involve resistant pathogens (primarily MRSA).

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.

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This release was published on openPR.