Clinical Trials on Anti-Biofilm Approaches Against Mycobacteria

1. CMTX-101 – a Biofilm-Disrupting Monoclonal Antibody

A clinical trial listed on ClinicalTrials.gov is evaluating CMTX‑101, a monoclonal antibody designed to disrupt bacterial biofilms as an adjunct to standard antibiotic treatment. Though the trial mentions “bacterial biofilm,” it does not explicitly specify Mycobacterium exposure in the publicly available summary. 

2. Preclinical Research (Animal Models)
• Monoclonal Antibody Targeting Mycobacterium abscessus Biofilms
In preclinical (murine) studies, researchers developed an epitope-targeted monoclonal antibody capable of rapidly dismantling biofilms formed by Mycobacterium abscessus, substantially reducing bacterial load and inflammation. 
• Small Molecule Compounds (e.g., NF1001)
Studies have highlighted novel compounds like NF1001, a thiopeptide antibiotic with potent activity against both planktonic M. abscessus and M. avium as well as their biofilm forms. 
• DNABII-Targeting Antibody (‘HuTipMab’)
Experimental investigations into biofilms of nontuberculous mycobacteria (NTM) have explored a humanized DNABII-targeted monoclonal antibody (HuTipMab) for its ability to disrupt biofilm matrices. 

These studies are promising, but they remain preclinical and haven’t progressed to national-level clinical trials yet.

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Broader Landscape: NTM Clinical Trials (Internal Focus)

A 2024 review surveyed clinical trials for NTM (non-tuberculous mycobacteria) therapies on ClinicalTrials.gov. The majority of these trials are focused on:
• Optimizing existing antibiotic combinations (e.g., amikacin, azithromycin, clofazimine, bedaquiline, linezolid)
• Dosage or regimen refinements for guideline-based therapy

However, the review found no indication that current trials are testing strategies specifically targeting biofilm disruption.