Clinical-stage biotechnology company Lakewood-Amedex Biotherapeutics Inc (NASDAQ:LABT) on Wednesday announced preclinical safety data for its Nu-3 gel formulation that establishes a strong foundation for clinical dose selection in an upcoming Phase 2a clinical trial.

Nu-3 is a gel formulation of a Bisphosphocin compound targeting the topical treatment of infected diabetic foot ulcers with low likelihood of producing systemic side effects.

According to Lakewood-Amedex Biotherapeutics, Nu-3 was well tolerated in the FDA-required safety study after administering dose levels substantially higher than the doses selected for the planned Phase 2a trial. Additionally, systemic exposure was very low, as anticipated, suggesting a low potential for systemic side effects.

Lakewood-Amedex Biotherapeutics is finalising preparation for a Phase 2a clinical trial in infected diabetic foot ulcers. The combined outcomes of in vitro antimicrobial activity and in vivo activity in animal models of wound infection, as well as the positive safety study outcome, support the dose selection of 2%, 5%, and 10% gels targeted for evaluation.