DENVER, Colo. (247marketnews.com) — Lakewood-Amedex Biotherapeutics (NASDAQ:LABT) is heading deeper into the clinical stage with its lead antimicrobial candidate Nu-3, and fresh laboratory data are giving the company another potential catalyst as its Phase 2a trial gets underway.
The company announced that Nu-3 demonstrated consistent antibacterial activity against recent clinical isolates collected from infected diabetic foot-ulcer patients at 14 U.S. medical centers, including both drug-resistant and susceptible strains of Staphylococcus aureus and Enterococcus faecalis. Importantly, the company said Nu-3’s antibacterial activity was not affected by the resistance phenotype.
Just days ago, Lakewood-Amedex announced that the first patient had been dosed in its Phase 2a trial, a dose-finding study evaluating 2%, 5% and 10% concentrations of topical Nu-3 in patients with mildly infected diabetic foot ulcers. Topline results are expected in the first quarter of 2027.
Monday’s results add another layer to the developing story because the isolates were sourced from actual infected diabetic-foot-ulcer patients rather than relying solely on laboratory reference strains. The company reported that Nu-3’s minimum inhibitory concentration values were 2-to-8 times below the planned clinical doses, which management characterized as supporting a favorable dosing margin.
“The positive MIC data in clinical isolates are another encouraging signal supporting continued study of Nu-3 and the Bisphosphocin class,” said CEO Kelvin Cooper, Ph.D. “Importantly, the data show clear and positive cidal activity against specific microbes isolated from real world patients.”
The underlying market opportunity is substantial. Lakewood-Amedex estimates that about one-third of people with diabetes develop diabetic foot ulcers and that roughly half of those ulcers become infected. The company also says approximately 15% to 20% of infected diabetic foot ulcers involve resistant pathogens, primarily MRSA.
Nu-3 is designed as a topical, locally delivered antimicrobial, potentially allowing the drug to attack microbes directly at the infection site. Lakewood-Amedex says its Bisphosphocin technology rapidly disrupts microbial membranes and has shown activity against resistant organisms in laboratory testing.
The company has been stacking milestones ahead of the 2027 readout. In September, it secured IRB approvals and confirmed clinical-site readiness, followed by first-patient dosing on Sept. 24. The Phase 2a program is expected to inform dose selection for a subsequent Phase 2b study.
The key distinction is that Monday’s MIC findings are in vitro data, not clinical efficacy results.
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