"These preclinical results are highly encouraging, providing evidence that our Nu-3 gel formulation has the potential to be a safe and effective, topically delivered antimicrobial," said Kelvin Cooper, Ph.D., Chief Executive Officer of Lakewood-Amedex Biotherapeutics. "Safety data confirms that Nu-3 was well-tolerated and did not inhibit wound-healing in the safety study, which gives us confidence in the therapeutic index of Nu-3 as we near the expected initiation of our Phase 2a study."

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 finalizing preparation of a Phase 2a clinical trial in infected diabetic foot ulcers (iDFU). 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, supports the dose selection of 2%, 5%, and 10% gels targeted for evaluation in the upcoming Phase 2a trial.

"Based on the preclinical data, including the safety study, the gel formulation of Nu-3 has the potential to be uniquely suited for the treatment of infected diabetic foot ulcers with broad-spectrum efficacy, fast-acting antimicrobial activity, as well as activity against highly resistant bacterial strains and complex biofilms," stated Thomas Balzer, M.D., Ph.D., Chief Medical Officer of Lakewood-Amedex Biotherapeutics. "The selected concentrations are expected to provide sufficient dose response information both for the antimicrobial activity in patients as well as safety and tolerability of Nu-3, as a topical formulation that ensures a localized therapeutic impact with a low risk of systemic side effects."