Lakewood-Amedex Biotherapeutics Announces Preclinical Safety Data Supporting Clinical Dose Selection for Upcoming Phase 2a Trial of Nu-3 Gel
Nu-3 is a gel formulation of a Bisphosphocin® compound targeting the topical treatment of infected diabetic foot ulcers with low likelihood of producing systemic side effects.
SARASOTA, Fla., July 15, 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, announced robust preclinical safety data that establishes a strong foundation for clinical dose selection in its upcoming Phase 2a clinical trial.
"These preclinical results are highly encouraging, providing evidence that our Nu-3 gel formulation has the potential to be a safe and effective, topically delivered antimicrobial," said Kelvin Cooper, Ph.D., Chief Executive Officer of Lakewood-Amedex Biotherapeutics. "Safety data confirms that Nu-3 was well-tolerated and did not inhibit wound-healing in the safety study, which gives us confidence in the therapeutic index of Nu-3 as we near the expected initiation of our Phase 2a study."
Nu-3 was well tolerated in the FDA-required safety study after administering dose levels substantially higher than the doses selected for the planned Phase 2a trial. Additionally, systemic exposure was very low, as anticipated, suggesting a low potential for systemic side effects.
Lakewood-Amedex Biotherapeutics is finalizing preparation of a Phase 2a clinical trial in infected diabetic foot ulcers (iDFU). The combined outcomes of in vitro antimicrobial activity and in vivo activity in animal models of wound infection, as well as the positive safety study outcome, supports the dose selection of 2%, 5%, and 10% gels targeted for evaluation in the upcoming Phase 2a trial.
"Based on the preclinical data, including the safety study, the gel formulation of Nu-3 has the potential to be uniquely suited for the treatment of infected diabetic foot ulcers with broad-spectrum efficacy, fast-acting antimicrobial activity, as well as activity against highly resistant bacterial strains and complex biofilms," stated Thomas Balzer, M.D., Ph.D., Chief Medical Officer of Lakewood-Amedex Biotherapeutics. "The selected concentrations are expected to provide sufficient dose response information both for the antimicrobial activity in patients as well as safety and tolerability of Nu-3, as a topical formulation that ensures a localized therapeutic impact with a low risk of systemic side effects."
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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SOURCE Lakewood-Amedex Biotherapeutics Inc.