Lakewood-Amedex Completes Multikilogram cGMP Manufacturing and Five-Year Stability for Nu-3 Gel
Lakewood-Amedex has completed multikilogram cGMP manufacturing of its lead antimicrobial Nu-3 gel formulation and active ingredient, achieving enhanced cost of goods and improved physical chemistry characteristics. Stability testing shows five-year bulk substance and two-year gel formulation stability with undetectable bioburden, supporting a planned Phase 2 trial in diabetic foot ulcers.
1. Manufacturing Process Development
Lakewood-Amedex has completed drug substance and gel formulation process development under cGMP guidelines, manufacturing multikilogram quantities of the Bisphosphocin® active ingredient and Nu-3 gel with improved cost efficiency and physical chemistry profiles.
2. Stability and Bioburden Results
Stability testing demonstrated that the Nu-3 bulk drug substance remains stable for at least five years, while the gel formulation shows two-year stability with undetectable bioburden and sustained antimicrobial effectiveness without preservatives.
3. Phase 2 Clinical Trial Plans
The Company plans to advance Nu-3 into a placebo-controlled Phase 2 clinical trial in mildly infected diabetic foot ulcers, including an initial Phase 2a safety and dose-response study followed by a Phase 2b dose comparative study.
4. Broader Indication Potential
With a mechanism that rapidly destabilizes bacterial membranes and efficacy against MRSA and VRE in vitro, Bisphosphocin® compounds may also be adapted for complicated urinary tract and pulmonary infections.