SHELTON, CONNECTICUT – Tuesday, June 11, 2024 -- NanoViricides, Inc. (NYSEAmer.: NNVC) (the "Company"), a clinical-stage global leader in broad-spectrum antiviralnanomedicines, reports that its clinical stage lead nanoviricide broad-spectrum antiviral drugcandidate, NV-387, results in an ideal flat blood concentration profile for an extended time periodupon oral administration in two different animal models.This unusual but highly desirable, extended flat time profile of blood concentration of orallygiven NV-387 enables sustained antiviral effect over a long period of time, allowing infrequentdosing regimens.
The blood concentration of NV-387 increased to a peak in approximately the first hour, and thenremained almost constant for eight hours or longer, thereafter, the concentration declined to reachbaseline at about twelve hours; upon oral administration of a first dose of NV-387. This wasfound to be the case in studies involving two different animal models, namely, rats and dogs.After repeated dosings, the plateau of the sixth dose lasted for at least 24 hours, thereafterdeclining to baseline at about 36 hours, in both the rat and dog animal models.The same plateau profile phenomenon was observed in both male and female animals, as well asin both species of animals, namely, rat and dog.
The blood concentration profile of NV-387 is indicative of the formation of a buffering reservoirof the drug in the host that releases the drug at a regular rate into the bloodstream.The Company has recently reported that NV-387, when given as a slow bolus intravenousinfusion, was found to result in a relatively flat plateau of blood concentration of the drug withvery slow decline over a 24 hour period in a cynomolgus monkey model.The flat time profile of NV-387 indicates that even at very high dosings, its blood concentration isunlikely to result in unwanted side effects. Typical drugs result in a rapid rise in bloodconcentration of the drug in generally the first hour to a peak, thereafter rapidly exponentiallydecreasing to baseline in 3-6 hours. In order to ensure that the concentration of the drug issufficiently high to provide antiviral effect at say 2-4 hours from dosing, the drug dose chosenwould be relatively high, and can therefore result in a substantially greater drug concentration inthe beginning, which can result in unwanted side effects. Therefore, a sustained, nearly flat drugconcentration profile is highly sought-after.
In the repeat-dose oral NV-387 administration studies in both rat and dog models cited above, twodoses were given on the first day (at 0h and 12h), followed by third dose at 24 h, and then dailydoses at 24 hour intervals, for a total of six doses in five days.
The Company has previously reported that NV-387 when administered orally resulted in strongantiviral effects in several respiratory viruses. In lethal infections with hCoV- NL63 (a model forSARS-CoV-2, cause of COVID), RSV, as well as Influenza A/H3N2, orally administered NV-387was found to be superior to approved therapeutics where available.
In fact, the Company has found that NV-387 enabled complete cure of RSV infection in themouse model of lethal lung infection with RSV A2.
The Company therefore believes that NV-387 is a first-in-class, broad-spectrum antiviral agentthat could be a revolutionary single drug for the treatment of a multitude of respiratory viralinfections including RSV, COVID, Influenzas and potentially other viruses.
The presented non-clinical studies of pharmacokinetics of orally administered NV-387 providesupport that the strong antiviral effect seen in these antiviral animal model efficacy studies is theresult of NV-387 circulating in the body and exerting its direct antiviral effects."NV-387 is a unique host-mimetic, direct acting antiviral drug that the virus is highly unlikely toescape," said Anil R. Diwan, Ph.D, President, "We were pleasantly surprised that NV-387 ishighly active upon oral administration, and now we have found that this is because it indeedcrosses into the bloodstream upon oral administration, enabling systemic antiviral effects." Hefurther explained that, "NV-387 may be the very first or one of very few nanomedicines that areeffective upon oral administration. Nanomedicines in general are restricted to injectable or topicaldelivery. NV-387 is thus unique in this respect."
NV-387 has recently completed Phase I human clinical safety tolerability studies with no reportedadverse events in India, as the Company has reported previously.
About NanoViricides
NanoViricides, 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.
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NanoViricides, Inc.!
info@nanoviricides.com
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Source: NanoViricides, Inc.