A Novel Broad-Spectrum Antiviral Against Influenza A Viruses, NV-387, Is Effective in Protecting Lungs from Damage in Lethally Infected Animal Model

SHELTON, CT / ACCESSWIRE / June 20, 2024 / NanoViricides, Inc. (NYSE AmerIcan.:NNVC) (the "Company"), a clinical stage company and global leader in broad-spectrum antiviral nanomedicines, reports that the ultra-broad-spectrum antiviral NV-387, a clinical Phase II stage drug candidate, was found to be effective in protecting lungs from damage in a lethally infected Influenza A H3N2 mouse model.

"We believe that the lung protection afforded by NV-387 is a very important result. The most severe cases that lead to hospitalization and fatalities in respiratory viral infections involve lung damage as an important factor," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "This was starkly evidenced during COVID-19 pandemic wherein the Delta variant that caused severe lung damage also caused the largest number of hospitalizations and fatalities. Influenzas, RSV, COVID can all cause severe lung damage resulting in fatalities."

1. NV-387 Treatment Resulted in Significant Reduction in Lung Infiltration and Lung Cell Death

Lungs of infected animals treated with NV-387, orally or intravenously, showed very limited presence of infiltrating cell-killing immune cells that are known to be an important cause of lung damage, in addition to the direct lung damage from infected cell death caused by the virus itself.

Further, the overall lung damage was significantly reduced upon NV-387 treatment.

On day 7 post-infection, NV-387 oral treatment resulted in only about 31% lung infiltration by immune system cells, and NV-387 intravenous treatment resulted in an even lower, about 22%, infiltration rate, whereas the lungs of infected untreated animals had a very high 68% infiltration rate (smaller is better), as determined by micro-histopathology of lung tissues using specific staining techniques.

2. NV-387 Treatment Resulted in Significant Reduction in Mucus Load in the Lungs

Additionally, the extent of mucus in the lung tissue was substantially reduced in the case of oral as well as intravenous NV-387 treatment. The mucus index value in the case of NV-387 oral treatment was about 53, and for intravenous NV-387 treatment it was about 32, as compared to the infected untreated animals that had a mucus index value of 138 (smaller is better).

Mucus is secreted by secretory cells in response to viral infection in an attempt to clear the virus, but it results in reduced lung capacity and eventually can lead to pneumonia. Thus reduction in mucus load is an important sign that the progress of the viral infection is arrested.

These results indicate that NV-387 treatment led to a significant level of protection of lungs in Balb-c mice lethally infected with Influenza A H3N2 virus.

3. NV-387 Treatment Resulted in Significantly Greater Survival Improvement Compared to Three Approved Influenza Drugs

Previously, we reported from this same animal study that NV-387 treatment led to substantially longer animal survival compared to the three approved influenza drugs, namely Oseltamivir (Tamiflu ®, Roche), Rapivab (Peramivir, BioCryst), and Baloxavir (Xofluza®, Shionogi, Roche).

NV-387 treatment, both intravenous and oral, led to increase in survival of animals by a substantial 88% over the infected untreated controls, whereas the three approved drugs only increased survival marginally, by about 25% to 38%. These results indicate that NV-387 was substantially superior to the three approved influenza drugs in this animal study.

The above results demonstrate that NV-387 possesses strong antiviral activity against Influenza viruses.

4. Viral Resistance to NV-387 is Unlikely as Opposed to Known Evolution of Viral Resistance Against Currently Approved Drugs

Baloxavir resistant mutants were found to develop in as many as 10% of treated patients in its Phase III clinical trials. Oseltamivir resistant mutants are known and circulating, and they exhibit resistance to Peramivir as well.

In contrast, even as influenza viruses mutate, they would be highly unlikely to escape NV-387. This is because NV-387 is an ultra broad-spectrum antiviral that is designed as a host-mimetic (See paragraph (a) below).

5. NV-387 Has Completed Phase I Human Clinical Trial

There were no reported adverse events, and there were no dropouts in the Phase I human clinical trial of NV-387, indicative of excellent safety and tolerability of NV-387. This drug candidate is thus ready for further development in Phase II clinical trials.

In summary, NV-387 is poised to become a very important drug in the fight against Influenza viruses, we believe.

(a). Host-Mimetic Nanoviricide Drug Candidate NV-387 is Designed to Attack Many Viruses; with Escape of Virus Unlikely

All influenza viruses bind to the host's sulfated proteoglycans ("S-PG") as primary attachment receptors and cellular sialic acids as cognate receptors; the latter enabling entry into cells. NV-387 is designed to copy the invariant or conserved features of S-PG and present itself like a human cell decoy to the virus. As the virus binds to the NV-387 metamorphic ("shape-shifter") micelle, the NV-387 polymer chains are expected to wrap onto the virus surface, via a well known process called "lipid-lipid fusion", merging the lipid chains of the NV-387 polymer with the lipid coat of the virus particle. This is expected to result in destabilization of the virus, uprooting the H and N proteins from the virus surface, thereby making the virus incapable of attacking human cells.

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.