Ceragenins are non-peptide small molecule mimics of endogenous antimicrobial peptides. They display broad-spectrum antibacterial, antifungal and antiviral activity against lipid-enveloped viruses including SARS-CoV-2 (COVID-19). In vitro and in vivo studies have established this activity.
Used as a nebulized, aqueous formulation for prevention and possible treatment of viral infection and secondary bacterial infections in the sinuses and lung.
Test results for Virucidal Efficacy testing performed at Analytical Lab Group on March 23, 2020.
Dried Virus Control Results:
Cytotoxicity Control Results:
All test control results met acceptance criteria for a valid test. Test results meet EPA criteria for a virucidal label claim.
Ceragenins formulated in micelles are well tolerated at high concentrations in the lung and trachea while retaining antimicrobial activity. Although anecdotal, the Ceragenin-containing products used for animal care have been used for treatment in the lungs of racehorses for years with good results and no adverse events. In the description of uses of Ceragenin given below, the term CSA refers to these Ceragenin-containing products.
SARS-CoV-2 virus has entry factors that are highly expressed in nasal and bronchial epithelial cells together with innate genes to gain entry into human cells and cause infection. The virus has strong affinity and tropism for the respiratory epithelial cells. Gene array studies show that Ceragenins downregulate expression of IRAK proteins and TNF-α. In addition, Ceragenins modulate the body’s innate immune response against viruses.
Kills secondary infection without resistance and pathogenic fungi – Excellent data showing Viricidal activity to SARS-CoV-2 with Ceragenins.
Ceragenins effectively mimic key components of innate immunity, providing continuous protection against pathogens ranging from bacteria to fungi to viruses. The continuity and breadth of activity of innate immunity is essential due to constant exposure to a broad array of pathogens. A key component of innate immunity is endogenous antimicrobial peptides (AMPs). Ceragenins are small-molecule mimics of AMPs and are derived synthetically from a common bile acid.
Ceragenins has been safely studied in many in-vitro studies and in-vivo studies and peer reviewed papers have been written about this new technology. Recently Ceragenin coated endotracheal tubes have been evaluated in two pivotal studies and this showed good safety and efficacy as a medical device.
The CSA coated endotracheal tube was designated a “breakthrough device” by the FDA and has recently been granted emergency use authorization in Canada.
Scanning Electron Microscopy (SEM) images of ETT surfaces: A: biofilm of C. auris (CDC 383) on an uncoated tube after 14 days (daily inoculation). B: surface of a coated tube after 14 days (daily inoculation with C. auris). C: mixed species biofilm of MRSA and PA01 on an uncoated tube after 48 h. D: surface of a coated tube after 48 h (inoculation with MRSA and PA01). E: mixed species biofilm of PA01 and C. auris on an uncoated tube after 48 h. F: surface of a coated tube after 48 h (inoculation with PA01 and C. auris).
No study to date has shown any related adverse events.
Supporting documentation available upon request.