Lakewood-Amedex Biotherapeutics Inc (NASDAQ:LABT), a clinical-stage biotechnology company focused on advancing a novel class of potent, fast-acting, broad-spectrum antimicrobials for infectious diseases called the Bisphosphocin class, on Monday reported positive Minimum Inhibitory Concentration (MIC) 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 (iDFU) with topline data expected in the first quarter of 2027.

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 utilised in the study were collected across 14 medical centres in the US from patients suffering from diabetic foot infections.

According to the company, 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 favourable 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 says that iDFUs represent a significant unmet medical need, affecting millions of patients worldwide and often leading to hospitalisation 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 50% of DFUs become infected, and 15–20% of iDFUs involve resistant pathogens (primarily MRSA).