SARASOTA, Fla., May 18, 2026
Key formulation, delivery and manufacturing steps completed in preparation for planned Phase 2 clinical trial
SARASOTA, Fla., May 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 positive data for its lead compound, Nu-3, as it advances towards a Phase 2 trial. Nu-3 is being developed as a topically delivered treatment for mildly infected diabetic foot ulcers (iDFU) designed to reduce the risk of antimicrobial resistance (AMR).
The Company has conducted drug substance (the active ingredient) manufacturing process development for a few members of the Bisphosphocin® class and has completed several multikilogram scale under current Good Manufacturing Practices (cGMP) guidelines with high efficiency. In addition, process development advances have improved the cost of goods and have produced bulk drug substance with enhanced physical chemistry characteristics. The Company has also conducted drug product (the gel formulation) manufacturing process development and multikilogram quantities of the Nu-3 gel formulation have been manufactured under cGMP guidelines, and the product is suitable for use in clinical trials.
"Lakewood-Amedex Biotherapeutics has worked diligently to optimize formulation and manufacturing processes required to produce both the Bisphosphocin® drug substances and drug products," said Kelvin Cooper, Ph.D., Chief Executive Officer at Lakewood-Amedex Biotherapeutics. "The Bisphosphocin® class of compounds are modified nucleotide molecules with excellent aqueous solubility, potentially making them adaptable to a range of different drug product formulations and delivery methods, which could have significant potential in additional indications such as complicated urinary tract infection (cUTI) and pulmonary infections. We look forward to advancing the current Nu-3 gel formulation into a planned Phase 2 clinical trial targeting iDFU."
In key stability testing, the Company has shown that the Nu-3 bulk drug substance material is stable for at least five years, and further examinations of the Nu-3 formulation have shown the drug product to be stable for at least two years. In addition, initial testing for bioburden (the presence of viable microorganisms) and antimicrobial effectiveness has demonstrated that the drug product has undetectable bioburden levels for at least two years and does not require additional preservatives to maintain antimicrobial effectiveness.
The Bisphosphocin® class of compounds has been shown in vitro to rapidly kill bacteria through a pH and concentration dependent destabilization of the bacterial cell membrane. This mechanism of action offers the potential to reduce the threat posed by antibiotic-resistant bacterial strains, including Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococci (VRE), and others.
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.
About Nu-3
Nu-3 is Lakewood-Amedex Biotherapeutics Inc.'s lead product being developed for the topical treatment of mildly infected diabetic foot ulcers (iDFU). Nu-3 belongs to a novel class of antimicrobials being developed by Lakewood-Amedex Biotherapeutics Inc. called the Bisphosphocin® class, which possess a unique mechanism of action that enables rapid elimination of a broad spectrum of bacteria, including resistant pathogens and biofilms. Data from initial exploratory clinical trials with Nu-3 using subclinical doses did not reveal any safety signals and showed a trend of positive antimicrobial response and improved wound healing. Based on these results, the Company plans to conduct an initial Phase 2a safety and dose response study of Nu-3 followed by a placebo-controlled Phase 2b dose comparative study. This study is also designed to determine the most appropriate administration regimen for Nu-3 gel formation in mildly infected diabetic foot ulcers.
Forward-Looking Statements
This press release may contain forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Generally, the words "believe," "expect," "intend," "estimate," "anticipate," "project," "will" and similar expressions identify forward-looking statements, which generally are not historical in nature. However, the absence of these words or similar expressions does not mean that a statement is not forward-looking. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. Management believes that these forward-looking statements are reasonable as and when made. However, caution should be taken not to place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. Our Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause our Company's actual results to differ materially from historical experience and our present expectations or projections.
Relying on such statements involves risk, uncertainty and assumptions. These statements are based on the current estimates and assumptions of the management of Lakewood‐Amedex Biotherapeutics Inc. as of the date of this press release and are subject to uncertainty and changes. All statements obtained in this press release are made only as of the date of this press release and Lakewood‐Amedex Biotherapeutics Inc. does not undertake any obligation to publicly update any forward‐looking statements.
Contact
Investor Relations
Tiberend Strategic Advisors, Inc.
David Irish
(231) 632-0002
dirish@tiberend.com
Media Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
646-577-8520
cmcdonald@tiberend.com
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SOURCE Lakewood-Amedex Biotherapeutics Inc.
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