Lakewood-Amedex Biotherapeutics completes key scale-up steps for lead antimicrobial gel
Lakewood-Amedex Biotherapeutics (NASDAQ:LABT) announced positive chemistry, manufacturing, and controls (CMC) data supporting the late-stage development of its lead antimicrobial candidate, Nu-3.
The clinical-stage biotechnology company, which specializes in developing a novel class of fast-acting, synthetic broad-spectrum antimicrobials known as Bisphosphocins®, successfully finalized key formulation, topical delivery validation, and current Good Manufacturing Practice (cGMP) scale-up milestones.
The operational advancements have successfully optimized the company's manufacturing cost of goods (COGS).
By leveraging high-yield chemical synthesis models, Lakewood-Amedex has generated its initial multikilogram batches of specialized Nu-3 topical gel.
This batch volume provides sufficient clinical supply to fully support its upcoming Phase 2 clinical trial, which will evaluate the therapeutic's safety and efficacy in patients presenting with mildly infected diabetic foot ulcers (iDFUs).
Diabetic foot ulcers represent a massive and growing global public health burden, affecting roughly one-third of the estimated 830 million individuals living with diabetes worldwide.
Because peripheral arterial disease frequently compromises circulation in diabetic individuals, systemic oral or intravenous antibiotics struggle to reach effective concentrations at the localized ulcer site.
Approximately half of these lesions eventually become infected, with 15% to 20% of cases driven by multi-drug resistant (MDR) pathogens like Methicillin-resistant Staphylococcus aureus (MRSA).
Unlike traditional systemic drugs, Nu-3 is formulated as a direct-application topical gel, allowing clinicians to deliver a highly concentrated bactericidal and fungicidal agent straight to the infection pocket with minimal systemic toxicity.
Long-term product stability testing further validated the commercial feasibility of the platform.
Recent real-time and accelerated storage assessments confirmed that the active Nu-3 drug substance maintains rigorous molecular integrity and stability for at least five years.
Furthermore, the specialized topical gel delivery matrix demonstrated a shelf-life stability profile of at least two years.
Crucially, the gel achieved this structural endurance while maintaining an undetectable bioburden over the testing period without the addition of any chemical preservatives.
The manufacturing milestones build upon a series of recent operational steps for the company, following its successful direct listing on the Nasdaq Capital Market in late April 2026.
To coordinate the upcoming clinical push, Lakewood-Amedex finalized a master service agreement with the Pharmaceutical Enrollment Research Institute (PERI) to serve as the lead Contract Research Organization (CRO) for the multicenter Phase 2 trial.
Patient recruitment and initial investigator site activations for the iDFU clinical program remain on track to commence around the mid-2026 timeframe.
