Lakewood-Amedex Received Approval for Nu-3 Clinical Trial
The firm secured Institutional Review Board approval to begin a Phase 2a trial for its topical gel wound treatment.
Updated on Sept. 19, 2026 in Biotech
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Lakewood-Amedex Biotherapeutics has received Institutional Review Board approval to proceed with a Phase 2a clinical trial of its product candidate, Nu-3. The company has confirmed that its clinical sites are ready to begin evaluating the topical gel.
Why it matters
The development aims to address significant medical needs regarding drug-resistant wound infections in patients. These efforts align with federal mandates from the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria.
Nu-3 is a topical gel in the Bisphosphocin antimicrobial class that works by destabilizing microbial cell membranes to avoid resistance. Preclinical data confirmed the gel was well-tolerated and improved patient antimicrobial responses.
The players
Lakewood-Amedex Biotherapeutics
This biotechnology firm specializes in developing novel antimicrobial treatments aimed at combating drug-resistant bacterial strains.
Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
This federal advisory body provides recommendations and mandates to coordinate national efforts against the rise of antibiotic-resistant pathogens.
The details
The Phase 2a trial is designed to evaluate the safety and efficacy of the gel when applied to mildly infected diabetic foot ulcers. By utilizing a membrane-destabilizing mechanism, the treatment seeks to overcome common challenges associated with drug-resistant bacterial infections.
Timeline
September 19, 2026: The company announced IRB approval and site readiness.
The Big Picture
The clinical progression of Nu-3 represents a shift toward specialized antimicrobial therapies designed to bypass traditional resistance mechanisms. This trial directly follows the framework set by the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria.
For patients suffering from chronic diabetic foot ulcers, this trial represents a potential new treatment pathway for managing difficult, drug-resistant infections. The outcome of the Phase 2a study will determine if this topical gel becomes a viable medical option in future care settings.
The takeaway
The progression of this trial highlights the ongoing effort to introduce non-traditional antimicrobial treatments into clinical practice. Patients should monitor future study results to understand potential changes to standard wound care protocols.
Further reading
Learn more about the latest innovations in the Biotech sector.
More information
For more technical details, visit the Lakewood-Amedex corporate information page.
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