Lakewood-Amedex Biotherapeutics Inc (LABT) News & EventsLABTLakewood-Amedex Biotherapeutics Inc

Lakewood-Amedex Announces Positive Preclinical Data for UTI

Lakewood-Amedex Biotherapeutics announced positive preclinical data in urinary tract infection, or UTI, and pulmonary infection indications in animal models treated with Bisphosphocin compounds. 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, or 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, hospital acquired bronchial pneumonia, and ventilator acquired bronchial pneumonia, 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.

Lakewood-Amedex Biotherapeutics Reports Positive Clinical Data for Nu-3

Lakewood-Amedex Biotherapeutics announced positive Minimum Inhibitory Concentration 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 with topline data expected in the first quarter of 2027. "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.

Lakewood-Amedex Biotherapeutics Begins Phase 2a Trial for Nu-3

Lakewood-Amedex Biotherapeutics announced that the first patient has been dosed in its Phase 2a clinical trial evaluating Nu-3 for the treatment of patients with mildly infected diabetic foot ulcers. The initiation of patient dosing represents a significant milestone for Lakewood-Amedex Biotherapeutics and the clinical advancement of Nu-3, a topically applied antimicrobial gel designed to rapidly eliminate microbes directly at the site of infection while addressing important limitations of conventional treatments, including antimicrobial resistance. The Phase 2a study is designed to evaluate the safety and efficacy of three concentrations of Nu-3 and inform dose selection for the company's continued clinical development program. Topline data from the Phase 2a study are expected in the first quarter of 2027.