Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) announced the completion of key formulation, delivery and manufacturing processes for its lead compound Nu-3, preparing for a planned Phase 2 clinical trial targeting infected diabetic foot ulcers.

The Sarasota, Florida-based biotechnology company said it has manufactured multikilogram quantities of both the drug substance and gel formulation under current Good Manufacturing Practices guidelines. The company reported that process development advances have improved cost of goods and produced bulk drug substance with enhanced physical chemistry characteristics.

Stability testing showed the Nu-3 bulk drug substance remains stable for at least five years, while the formulation demonstrated stability for at least two years. Testing for bioburden revealed undetectable levels of viable microorganisms for at least two years without requiring additional preservatives.

"Lakewood-Amedex Biotherapeutics has worked diligently to optimize formulation and manufacturing processes required to produce both the Bisphosphocin drug substances and drug products," said Kelvin Cooper, chief executive officer.

Nu-3 belongs to the company's Bisphosphocin class of antimicrobials, which the company states kills bacteria through pH and concentration dependent destabilization of bacterial cell membranes. The mechanism is designed to address antibiotic-resistant bacterial strains including Methicillin-resistant Staphylococcus aureus and Vancomycin-resistant Enterococci.

The company plans to conduct an initial Phase 2a safety and dose response study of Nu-3 followed by a placebo-controlled Phase 2b dose comparative study for mildly infected diabetic foot ulcers.

Information in this article is based on the company's press release statement.