Lakewood-Amedex Biotherapeutics (NASDAQ:LABT) reported positive preclinical antimicrobial data for Nu-3 against recent clinical isolates from infected diabetic foot ulcers, ahead of Phase 2a topline results expected in the first quarter of 2027.
Lakewood-Amedex reported positive Minimum Inhibitory Concentration data for Nu-3, its lead Bisphosphocin antimicrobial candidate currently being evaluated as a topical treatment for mildly infected diabetic foot ulcers.
The in vitro study tested Nu-3 against recent clinical isolates collected during the past three years from patients with diabetic foot infections at 14 U.S. medical centers.
Testing covered resistant and susceptible strains of Staphylococcus aureus, including MRSA and MSSA, as well as resistant and susceptible Enterococcus faecalis, including VRE and VSE.
According to Lakewood-Amedex, Nu-3 demonstrated consistent activity across the organisms tested, with results falling within the range previously observed in assays involving 285 clinical isolates across 15 species.
The company also reported that Nu-3’s antibacterial activity was not affected by whether the pathogens exhibited a drug-resistant phenotype. MIC values were two to eight times below the doses planned for clinical trials.
The new Nu-3 MIC data provide additional laboratory evidence supporting the candidate’s antimicrobial activity against pathogens relevant to infected diabetic foot ulcers, including strains resistant to existing antibiotics.
For investors, the resistance findings are particularly relevant to Nu-3’s intended positioning. Lakewood-Amedex is developing the Bisphosphocin class as fast-acting, broad-spectrum antimicrobials designed to kill microbes while reducing the risk of antimicrobial resistance.
However, the latest results are in vitro findings rather than evidence of clinical efficacy. Their significance will depend on whether the antimicrobial activity observed in laboratory testing translates into treatment benefits for patients in the ongoing Phase 2a trial.
The reported relationship between MIC levels and planned clinical doses also provides further information on the candidate’s preclinical dosing profile, but clinical results will be needed to establish Nu-3’s safety and efficacy in infected diabetic foot ulcers.
That makes the ongoing Phase 2a study the more consequential development milestone for the programme.
Lakewood-Amedex expects Phase 2a topline data for Nu-3 in mildly infected diabetic foot ulcers during the first quarter of 2027.
Those results should provide the next clinical assessment of whether Nu-3’s laboratory antimicrobial activity translates into outcomes in treated patients.
Investors can also watch for further information on activity against resistant pathogens, the candidate’s safety profile and any subsequent clinical-development plans following the Phase 2a readout.
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