Lakewood-Amedex Secured Approval for Nu-3 Clinical Trial

The company has received regulatory clearance to test a topical antimicrobial gel for diabetic foot ulcers.

Updated on Sept. 19, 2026 in Biotech

Isometric editorial illustration of a glass medical vial containing translucent gel on a clean laboratory surface. — Lakewood-Amedex Biotherapeutics received regulatory approval to begin a Phase 2a clinical trial for its topical antimicrobial gel, Nu-3, targeting diabetic foot ulcers. AI Illustration. Upload story photo >

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Lakewood-Amedex Biotherapeutics has received Institutional Review Board approval to begin a Phase 2a clinical trial of its topical gel candidate, Nu-3. The study will evaluate the safety and efficacy of the treatment in patients with mildly infected diabetic foot ulcers.

Why it matters

The development aims to address the clinical need for novel therapeutics capable of treating drug-resistant wound infections. The research aligns with federal mandates set by the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria.

Nu-3 is a topical gel belonging to the Bisphosphocin class of antimicrobials. The candidate outperformed prior preclinical safety benchmarks, demonstrating both high tolerability and an improved antimicrobial response.

The players

Lakewood-Amedex Biotherapeutics

A biotechnology firm focused on developing antimicrobial therapeutics using its proprietary Bisphosphocin platform.

Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria

A federal body that provides guidance and mandates for the development of new treatments for drug-resistant pathogens.

The details

The treatment functions by physically destabilizing microbial cell membranes, a process designed to evade traditional bacterial resistance pathways. In this Phase 2a trial, researchers will apply the gel formulation directly to infected diabetic foot ulcers to measure its safety and clinical efficacy.

September 19, 2026: The company announced receipt of Institutional Review Board approval and site readiness.

The Tech Race

Lakewood-Amedex is positioning Nu-3 against the backdrop of an urgent need for alternatives to conventional antibiotics that have been compromised by widespread resistance. This trial marks a critical milestone in moving the Bisphosphocin class from research into clinical application.

This development initiates the human safety and efficacy testing phase for a new wound-care option. Clinical availability remains pending the successful completion of this trial and subsequent regulatory review.

The takeaway

The transition of the Bisphosphocin class into human trials underscores the industry's shift toward membrane-destabilizing therapies to combat resistant bacteria. Stakeholders should monitor for trial completion data and subsequent Phase 3 entry announcements.