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Virpax - Model AnQlar -High-Density Molecular Intranasal Spray
An adjuvant to barrier-based personal protective equipment (PPE) to help mitigate the risks of poorly fitting equipment and over-used PPE with partially compromised barrier layers; AnQlar may be used as a frontline defense against disease spread in close settings; AnQlar may be used by vaccinated and unvaccinated individuals to prevent viral spread; Clinical and commercial manufacturing supply agreement in place; AnQlar shown to inhibit the ability of the virus to replicate at non-toxic concentrations; May prevent the spread of influenza and SARS-CoV-2 for 24 hours; May prevent brain viral load due to flu and SARS-CoV-2; Demonstrated >18 months stability; Targeted delivery in the nasal mucosa where viral infection starts.
TARGET MARKET
Prophylactic prevention of the spread of negatively charged viruses like Covid-19 and influenza
DELIVERY SYSTEM
Intranasal MET-nanoparticle dispersion delivery
MECHANISM OF ACTION
AnQlar and Quaternary ammonium chitosan (QAC) are highly related; Chitosan is a natural anti-microbial. Both are very positively charged mucoadhesive molecules that bind electrostatically to negatively charged coronaviruses. However, QACs are more toxic to the cells, making pH levels unacceptable for human use.
AnQlar’s modified chemical structure makes the molecule more hydrophilic than QAC. AnQlar’s hydrophilic property allow it to self assemble into nanoparticles in water to improve antiviral activity at pH levels acceptable for use in humans. AnQlar may have two mechanisms of action: it is virucidal and it prevents viral entry into cells via the angiotensin-converting enzyme-2 (ACE-2) receptor.
NEW DRUG APPLICATION (NDA)
If we successfully complete the required clinical trials for this product candidate, we intend to move forward and pursue an NDA for AnQlar as a once daily intranasal treatment.
The FDA has indicated that, upon successful completion of studies, we may pursue an NDA drug approval with the Office of Non-Prescription Drugs.