SHELTON, CONNECTICUT – Tuesday, June 4, 2024 -- NanoViricides, Inc. (NYSE Amer.: NNVC) (the "Company"), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, reports on the highly desirable blood concentration profile of its lead clinical stage broad-spectrum antiviral agent NV-387 upon intravenous (I.V.) administration in a nonhuman primate (NHP) animal model.
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 (Pfizer) hassignificant limitations for patient suitability. Thus a new drug against COVID and Long COVIDis sorely needed.
About NanoViricidesNanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a development stage companythat is creating special purpose nanomaterials for antiviral therapy. The Company's novelnanoviricide® class of drug candidates are designed to specifically attack enveloped virusparticles and to dismantle them. Additionally, nanoviricides mimick the host-side features that theviruses continue to require in spite of mutations, and therefore the viruses would be highlyunlikely to escape the nanvoricide drugs.
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 noreported adverse events even at the highest and repeated dosages. This trial was conducted by thedrug sponsor, Karveer Meditech Pvt. Ltd., our licensee and collaborator in India.
The Company is currently focused on advancing NV-387 into Phase II human clinical trials fortreatment 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 andgenital 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. NanoViricides' platform technology and programs are based on the TheraCour®nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricidesholds a worldwide exclusive perpetual license to this technology for several drugs with specifictargeting mechanisms in perpetuity for the treatment of the following human viral diseases:Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus(HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV),Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus,Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license forpoxviruses and/or enteroviruses if the initial research is successful. The Company's technology isbased on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas fromTheraCour Pharma, Inc. The Company's business model is based on licensing technology fromTheraCour Pharma Inc. for specific application verticals of specific viruses, as established at itsfoundation in 2005.
As is customary, the Company must state the risk factor that the path to typical drug developmentof any pharmaceutical product is extremely lengthy and requires substantial capital. As with anydrug development efforts by any company, there can be no assurance at this time that any of theCompany's pharmaceutical candidates would show sufficient effectiveness and safety for humanclinical development. Further, there can be no assurance at this time that successful results againstcoronavirus in our lab will lead to successful clinical trials or a successful pharmaceuticalproduct.
This press release contains forward-looking statements that reflect the Company's currentexpectation regarding future events. Actual events could differ materially and substantially fromthose projected herein and depend on a number of factors. Certain statements in this release, andother written or oral statements made by NanoViricides, Inc. are "forward-looking statements"within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the SecuritiesExchange Act of 1934. You should not place undue reliance on forward-looking statements sincethey involve known and unknown risks, uncertainties and other factors which are, in some cases,beyond the Company's control and which could, and likely will, materially affect actual results,levels of activity, performance or achievements. The Company assumes no obligation to publiclyupdate or revise these forward-looking statements for any reason, or to update the reasons actualresults could differ materially from those anticipated in these forward-looking statements, even ifnew information becomes available in the future. Important factors that could cause actual resultsto differ materially from the company's expectations include, but are not limited to, those factorsthat are disclosed under the heading "Risk Factors" and elsewhere in documents filed by thecompany from time to time with the United States Securities and Exchange Commission andother regulatory authorities. Although it is not possible to predict or identify all such factors, theymay include the following: demonstration and proof of principle in preclinical trials that ananoviricide is safe and effective; successful development of our product candidates; our abilityto seek and obtain regulatory approvals, including with respect to the indications we are seeking;the successful commercialization of our product candidates; and market acceptance of ourproducts.
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 indicateevaluation of safety or effectiveness by the US FDA.
"NOAEL" means "No-Observed-Adevrese-Event-Level", which is the maximum dosageemployed at which there were no adverse events found in animal studies.
"MTD" means "Maximum Tolerated Dose", which is the maximum dosage employed that doesnot compromise survival of the animals.
FDA refers to US Food and Drug Administration. IND application refers to "Investigational NewDrug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to"Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Productsfor Human Use, which is the European Medicines Agency's (EMA) committee responsible forhuman medicines. API stands for "Active Pharmaceutical Ingredient". API means activepharmaceutical ingredient.
Contact:
NanoViricides, Inc.
!info@nanoviricides.com
Public Relations Contact:
MJ Clyburn, TraDigital IR
clyburn@tradigitalir.com
Source: NanoViricides, Inc.