Lakewood-Amedex advances Nu-3 trial after 5 years of stability data

(Bloomberg) -- Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) is advancing its lead antimicrobial compound, Nu-3, toward a Phase 2 clinical trial after new data showed the drug substance is stable for at least five years. The trial will test the topical gel in patients with mildly infected diabetic foot ulcers (iDFU).

"The Bisphosphocin® class of compounds are modified nucleotide molecules with excellent aqueous solubility, potentially making them adaptable to a range of different drug product formulations and delivery methods," Kelvin Cooper, Ph.D., Chief Executive Officer at Lakewood-Amedex Biotherapeutics, said. "We look forward to advancing the current Nu-3 gel formulation into a planned Phase 2 clinical trial targeting iDFU."

The company announced it has completed key manufacturing and formulation steps, producing multikilogram quantities of the Nu-3 gel under cGMP guidelines. Stability tests showed the bulk drug substance is stable for at least five years, while the final gel formulation is stable for at least two years without the need for additional preservatives.

The advancement to a Phase 2 trial marks a significant step for the company's novel Bisphosphocin® platform, which targets a pressing need for new antimicrobials that can treat resistant bacteria. The company plans to conduct a Phase 2a safety and dose-ranging study, followed by a placebo-controlled Phase 2b study to determine the optimal administration regimen.

Unique Mechanism of Action

Nu-3 belongs to a novel class of antimicrobials called Bisphosphocins®, which have a unique mechanism that enables the rapid killing of a broad spectrum of bacteria, including resistant pathogens. In-vitro studies have shown the compounds work by destabilizing the bacterial cell membrane in a pH and concentration-dependent manner. This mechanism may reduce the threat posed by antibiotic-resistant strains such as Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant Enterococci (VRE).

Initial exploratory trials using subclinical doses of Nu-3 showed a positive trend in antimicrobial response and wound healing with no safety signals. The upcoming Phase 2 program aims to build on these findings to establish a clear dose and treatment plan.

The stability and manufacturing milestones de-risk the future development of Nu-3 and other compounds in the Bisphosphocin® class. Investors will be watching for the initiation of the Phase 2a trial and subsequent data readouts as the next major catalysts for the company.

This article is for informational purposes only and does not constitute investment advice.