A Novel Broad-Spectrum Antiviral with Activity Against Influenza A

NV-387 Possesses Strong Anti-Influenza-A Virus Activity, and May Have Activity Against H5N1 Bird Flu Virus, Says NanoViricides

SHELTON, CT / ACCESSWIRE / May 6, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a global leader in broad-spectrum antiviral nanomedicines, says that the ultra-broad antiviral activity spectrum of NV-387 includes Influenza A viruses, possibly including Bird Flu H5N1 virus as well.

NanoViricides reports that in a lethal animal model of lung infection by Influenza A /H3N2 virus, NV-387 was found to have substantially superior antiviral effects compared to three approved anti-influenza drugs.

We have recently performed a lethal lung infection study of mice infected with Influenza A/H3N2 that were treated with NV-387 or one of the three approved drugs for direct comparison: Oseltamivir (Tamiflu®, Roche), Peramivir (Rapivab®, Biocryst), and Baloxivir (Xofluza®, Shionogi, Roche). In this study, NV-387 Oral treatment led to a survival lifespan of 15 days, compared to 10 days with Oseltamivir Oral treatment, 11 days with Peramivir I.V. treatment, and 11 days with Baloxivir Oral treatment, while the vehicle-treated and untreated (infected) animals survived only 8 days.

Thus the anti-Influenza activity of NV-387 given orally was substantially superior to all three of the approved anti-influenza drugs, namely Tamiflu, Rapivab, and Xofluza.

Given the broad-spectrum of antiviral activity of NV-387 against viruses in many different virus families, we believe that its effectiveness against Influenza A/H3N2 is indicative of potential antiviral activity against most if not all Influenza A viruses.

In particular, we believe, based on structural information, that the H5 hemagglutinin of H5N1 bird flu virus may be even more susceptible to NV-387 attack than the H3 hemagglutinin of the H3N2 virus. This is because H5 contains a long polybasic site sequence, which has biochemical affinity from electrostatic interactions with the antiviral ligand used in NV-387. This antiviral ligand is a sulfated proteoglycan mimetic.

Thus it is very likely that NV-387 may have strong antiviral activity against the bird flu H5N1 virus, although further work is needed in this regard.

"We are pleasantly surprised by this extremely broad and strong antiviral activity of NV-387," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, adding, "We are close to having a single drug NV-387 for the treatment of all of the tripledemic respiratory viruses - Coronaviruses, RSV, and Influenza A, which would be a revolutionary achievement."

We note that all three approved influenza drugs oseltamivir, peramivir and baloxivir are known to be prone to viral escape by mutations. In contrast, NV-387 as a host-mimetic is highly unlikely to be escaped by the susceptible viruses.

To date H5N1 bird flu virus has caused only sporadic infections in humans that have been zoonotic in origin, most previous ones being from poultry to humans, while recently cases from cattle to human transmission have occurred. H5N1 has caused increasing spread in wild bird and poultry populations, and now has taken hold in several herds of dairy cattle. Recent reports by CDC indicate that the current H5N1 dairy virus has not incorporated mutations necessary for successful human infection and for human-to-human transmission.

This H5N1 was also found to be sensitive to oseltamivir. However, the influenza viruses in particular are known to change rapidly by mutations, recombinations, as well as re-assortments; the last one enabled by the multi-segmented nature of the virus genome. Eight RNA segments together make up its genome, and in a co-infection of two different influenza A viruses, interchange i.e. reassortment of these segments can take place leading to new variants. Rightly, public health officials are closely watching H5N1.

A safe and effective antiviral drug that the virus would not escape by simple mutations or field evolution is the holy grail of antiviral drug development. We believe that the NanoViricides Platform technology meets this challenge.

About NanoViricides

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 for the treatment of RSV, COVID-19, Long COVID, and other respiratory viral infections. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles (previously referred to as NV-HHV-101). The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-CoV-2 into Phase I/II human clinical trials.

NV-CoV-2 is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-CoV-2 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.

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. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting 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 for poxviruses and/or enteroviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.

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 NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they 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 publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to 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 our products.

The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient".

Contact:
NanoViricides, Inc.
info@nanoviricides.com

Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com

SOURCE: NanoViricides, Inc.