Lakewood-Amedex Biotherapeutics Announces Positive Data Against Recent Clinical Isolates from Infected Diabetic Foot Ulcers
The laboratory analysis used patient isolates collected at 14 medical centers across the United States.
Rhea-AI Summary
Lakewood-Amedex Biotherapeutics (LABT) reported laboratory activity for its topical antimicrobial candidate Nu-3 against bacteria from infected diabetic foot ulcers. Minimum inhibitory concentration (MIC) testing, which measures the concentration needed to stop bacterial growth in the lab, used patient isolates collected within the past three years. The tested bacteria included resistant and susceptible forms of Staphylococcus aureus and Enterococcus faecalis.
Nu-3 showed activity against all tested organisms, and drug-resistance status did not affect its antibacterial activity. The results were within the range of earlier assays involving 285 isolates across 15 species. MIC values were 2-8 times lower than planned clinical trial doses. Nu-3 is also being investigated as a topical treatment in a Phase 2a trial involving mildly infected diabetic foot ulcers, with topline data expected in the first quarter of 2027.
Details
Market move: LABT +47.28% vs previous close. Nu-3 clinical-isolate data
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Key Figures
- Clinical-isolate testing sites
- 14 medical centers
- U.S. centers supplying isolates from patients with diabetic foot infections
- MIC values versus planned doses
- 2-8 times lower
- Nu-3 testing against recent clinical isolates
- Prior assay isolates
- 285 clinical isolates
- Previous assay results referenced for comparison
- Prior assay species
- 15 species
- Species covered in the previous assay results
- Expected topline data
- First quarter of 2027
- Nu-3 Phase 2a clinical trial
Historical Context
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First patient dosed in the Nu-3 Phase 2a trial for infected diabetic foot ulcers.
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Nu-3 showed broad-spectrum in-vitro activity across resistance mechanisms without induced resistance in serial passage.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
mic medical
mrsa medical
mssa medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Lead candidate Nu-3 is a topically formulated Bisphosphocin®, designed to rapidly kill microbes while reducing the risk of antimicrobial resistance
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
"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
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
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.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Lakewood-Amedex's Nu-3 laboratory testing show?
Nu-3 showed activity against all tested organisms, including resistant and susceptible forms of Staphylococcus aureus and Enterococcus faecalis. Drug-resistance status did not affect its antibacterial activity in the laboratory testing.
When are Lakewood-Amedex's Nu-3 Phase 2a results expected?
Topline data from the Phase 2a trial are expected in the first quarter of 2027. The trial is investigating Nu-3 as a topical treatment for mildly infected diabetic foot ulcers.