The Company has found that its lead nanoviricide broad-spectrum antiviral drug candidateNV-387, when given as a slow bolus intravenous infusion, resulted in a relatively flat plateau ofblood concentration of the drug with very slow decline over a 24 hour period in a cynomolgusmonkey model.
The maximum concentration as well as the plateau concentration increased in a dose-dependentmanner, as expected.
This sustained drug level in the blood stream for a relatively long period of time enablesinfrequent dosing. It is the result of the unique polymeric design of NV-387. NV-387 is a'chemical nanomachine'. It is made up of polymer with its size chosen to minimize loss by renalfiltration.
The observed pharmacokinetic profile of NV-387 supports a once-daily or less frequent dosingregimen.
The Company has already developed an injectable formulation of NV-387, namely NV-387Solution for Injection, Infusion, and Inhalation.
An injection of NV-387 would be useful for moderate to severe illness, especially because of thesustained blood profile that requires infrequent dosing.
An infusion would be suitable for severely ill hospitalized patients.
Importantly, this NV-387 Solution can be readily delivered directly into the lungs of a patientusing a simple handheld nebulizer over a period of a few minutes. Such delivery can enable directattack on the virus where such attack is most needed in the cases of severe lung infection.
The utility of NV-387 is extremely broad, reminiscent of the utility of antibiotics.
We have found that NV-387 could cure lethal lung infection in RSV infected animals even withan oral dose. There is no approved drug for RSV treatment other than the toxic, last resort drugribavirin, which was not very effective in this lethal study compared to NV-387.
We have also found that NV-387 IV administration as well as PO (oral) administration wassubstantially superior to each of the approved drugs Tamiflu, Rapivab and Xofluza in anInfluenza A/H3N2 lethal lung infection model.
We believe that NV-387 is expected to possess similar strong antiviral activity against InfluenzaA/H5N1 'Bird Flu' viruses as well. Our belief is based on the putative mechanism of NV-387.
NV-387 is a host-mimetic, direct acting antiviral designed as decoy, to look like a cell decoratedwith sulfated proteoglycans, to which over 90% of human pathogenic viruses, including H5N1,are known to bind.
We have found that NV-387 has strong antiviral activity against all tested coronaviruses,including SARS-CoV-2 pseudovirions. NV-387 was substantially more effective than remdesivirin a lethal coronavirus infection animal study. We believe that NV-387 has a strong potential forthe treatment of COVID as well as 'Long COVID'.
COVID continues to cause substantially more fatalities annually than Influenza viruses. LongCOVID has substantial personal as well as societal costs. Available drug, Paxlovid (
About NanoViricidesNano
Our lead drug candidate is NV-387 (drug product NV-CoV-2) for the treatment of RSV, COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections.
NV-387 has successfully completed a Phase 1a/1b human clinical trial in healthy subjects with no reported adverse events even at the highest and repeated dosages. This trial was conducted by the drug sponsor,
The Company is currently focused on advancing NV-387 into Phase II human clinical trials for treatment of RSV infection.
Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 'coldsores' and HSV-2 'genital ulcers'. The Company cannot project an exact date for filing an INDfor any of its drugs because of dependence on a number of external collaborators and consultants.
The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu,H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.
As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by
The phrases 'safety', 'effectiveness' and equivalent phrases as used in this press release refer toresearch findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the
'NOAEL' means 'No-Observed-Adevrese-Event-Level', which is the maximum dosage employed at which there were no adverse events found in animal studies.
'MTD' means 'Maximum Tolerated Dose', which is the maximum dosage employed that does not compromise survival of the animals.
FDA refers to
Contact:
Email: info@nanoviricides.com
MJ Clyburn
Email: clyburn@tradigitalir.com
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