Intravesical administration of the Bisphosphocin® Nu-8 to rodents infected with E. coli demonstrated up to 97% inhibition of E. coli growth compared to no effect in a vehicle control group.
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, today announced positive preclinical data in urinary tract infection (UTI) and pulmonary infection indications in animal models treated with Bisphosphocin® compounds.
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In an animal model of UTI, intravesical administration of the Bisphosphocin® compound Nu-8 in rodents infected with E. coli resulted in up to 97% inhibition of E. coli growth with a 10% solution compared to no effect in a vehicle control group. In addition, the Bisphosphocin® class has demonstrated in vitro activity against a broad range of resistant bacteria, including those frequently found in UTI such as E. coli, K. pneumoniae, and P. aeruginosa, and has also demonstrated activity against biofilm-forming organisms. Complicated UTIs, especially catheter-associated urinary tract infections (CAUTI), are frequently caused by drug-resistant bacteria and bacterial biofilm.
Bisphosphocin® compounds, when administered as an aerosol formulation, have also demonstrated in vivo activity in animal models of pulmonary infections caused by Acinetobacter species, P. aeruginosa, and A. fumigatus. Additionally, the Bisphosphocin® class has demonstrated in vitro activity against a broad range of resistant bacteria frequently found in pulmonary infections such as H. influenzae, K. pneumoniae, and P. aeruginosa.
Pulmonary infections, such as community acquired bronchial pneumonia (CABP), hospital acquired bronchial pneumonia (HABP), and ventilator acquired bronchial pneumonia (VABP), are frequently caused by drug resistant bacteria. In addition, patients with cystic fibrosis have recurrent bacterial and fungal lung infections with organisms such as P. aeruginosa and A. fumigatus.
"We continue to be encouraged by the performance of different members of the Bisphosphocin® class of compounds when tested against various bacterial species, which are known to have a major impact on human health and are key contributors to the AMR crisis," said Kelvin Cooper, Ph.D., Chief Executive Officer and Senior Vice President of Research and Development at Lakewood-Amedex Biotherapeutics. "The Bisphosphocin® class of compounds possesses key characteristics including rapid and potent antimicrobial action and broad-spectrum activity with no expected resistance development, which could make them valuable assets in fighting the AMR crisis. We look forward to continuing development of the various Bisphosphocin® compounds to identify the most suitable candidate to be advanced into early clinical development."
Lakewood-Amedex Biotherapeutics' lead Bisphosphocin® candidate, Nu-3 formulated as a topical gel, is being studied in an ongoing Phase 2a trial of mildly infected diabetic foot ulcers (iDFU), with topline data expected in the first quarter of 2027.
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, the potential of Bisphosphocin® compounds in urinary tract and pulmonary infection indications, plans to identify and advance a candidate into clinical development, 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, including results in animal models or in vitro studies, may not be predictive of future results or replicated in humans; 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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