The Albany Gazette - NanoViricides Comments on the Need for Broad-Spectrum Antivirals in Light of the Current Influenza Wave - NV-387 is Effective Against H3N2

This year has been a "moderately severe" flu season according to CDC. The new subclade K variant of Influenza A/H3N2 is causing more than 80% of the cases. CDC estimates that there have been at least 15,000,000 illnesses, 180,000 hospitalizations, and 7,400 deaths from flu as of January 6 this season (https://www.cdc.gov/fluview/surveillance/2025-week-53.html).
The seasonal influenza vaccine, which always lags the actual field viruses, was mismatched, and contains an older subclade J of H3N2, making it substantially less effective. Every season, new influenza vaccines have to be created because the influenza virus changes rapidly. Despite that, Influenza vaccine mismatch occurs frequently. Influenza seasonal vaccine efficacy in unmatched years has been reported to be as low as 11-17% ^[1].

Two Influenza antivirals exist, namely Tamiflu (oseltamivir), and Xofluza (baloxavir). Any of these antivirals needs to be taken within 48 hours for it to be moderately effective. Importantly, Influenza viruses can rapidly become resistant to both of these antivirals.

In contrast, the broad-spectrum nanoviricide drug candidate NV-387 is highly unlikely to be defeated by viruses, because it copies the essential cell-side (host-side) feature that these viruses require, and do not mutate away from, called heparan sulfate.

Clearly, the current severe influenza epidemic demonstrates how valuable NV-387 will be as an antiviral. Additionally, NV-387 is active against Coronaviruses, RSV, and many other viruses that use heparan sulfate or related features for attacking human cells and causing an infection.

In fact, it is estimated that NV-387 would play in a market size of well over $20 Billion as a dominant player, if approved for emperic therapy of viral ARI/SARI (Acute or Severe Acute respiratory Infections).

NanoViricides' Current Antiviral Drugs Pipeline: NV-387, A Revolutionary Broad-Spectrum Antiviral with Multiple Indications

The Phase II clinical stage revolutionary broad antiviral spectrum of NV-387 is reminiscent of the dawn of antibiotics to combat bacterial infections. Over 90% of human pathogenic viruses use heparan sulfate features, which NV-387 copies and presents to fool the virus.

NV-387 is designed to attack the virus particle and destroy it by fooling the virus to enter the NV-387 nanomicelle using the same features that the virus uses to infect cells.

Viruses cannot escape NV-387 despite all the changes in the field because the virus still needs to bind to heparan-sulfate like features in order to cause productive pathogenic infection. NV-387 presents copious amounts of these binding sites to the virus, thereby engulfing the virus particle. Viruses are unlikely to escape NV-387 because no matter how much a virus evolves, it continues to utilize and require binding to sulfated proteoglycans - the very characteristic that NV-387 emulates.

This solves the long-standing problem of antiviral medicines, that viruses escape them. Vaccines, antibodies and small chemical drugs are readily escaped by viruses as the viruses evolve in the field. This has been repeatedly observed during the recent COVID-19 pandemic, as well as in the course of most of the other viral epidemics including Influenza and HIV/AIDS.

NV-387 for Influenza and Bird Flu

NV-387 was found to be substantially superior to Tamiflu as well as Xofluza against Influenza virus A/H3N2 in animal model studies of Influenza A/H3N2 lethal lung infection ^[2].

Further, should Bird Flu H5N1 turn into a human outbreak, variants resistance to Tamiflu and Xofluza can be expected to generate rapidly ^[3]. NV-387 would be the ideal drug to combat the resulting outbreak, epidemic or pandemic. The causative influenza virus would not be able to escape NV-387 ^[4].

NV-387 for All Respiratory Viral Infections

A Phase II clinical trial for the evaluation of NV-387 as a first line therapy of any respiratory viral infection (NV-387 for the treatment of Viral Acute or Severe Acute respiratory Infections, Viral ARI/SARI) is being planned. Success in this clinical trial would enable NV-387 to become the first ever antiviral drug that can be prescribed by a physician based on symptoms, as an emperic therapy for respiratory viral infections, without having to test for which virus is causing the disease.

NV-387 was found to be highly effective against the "tripledemic" respiratory viruses, namely RSV, Influenza A, and Coronaviruses, in respective lethal animal models of lung infection. NV-387 was found to be substantially superior to existing drugs, and even resulted in complete cure in the RSV animal study. These studies prompted evaluation of NV-387 as a first line therapy of respiratory viral infections.

There is no treatment approved for RSV, an important disease for infants and children in early life, as well as for geriatric subjects.

ABOUT NANOVIRICIDES

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. 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-387 into Phase II human clinical trials.

NV-CoV-2 (API NV-387) 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-387 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 RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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". WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
[email protected]

Public Relations Contact:
[email protected]

^[1] Yegorov S et al., Effectiveness of influenza vaccination to prevent severe disease: a systematic review and meta- analysis of test-negative design studies, Clinical Microbiology and Infection, https://doi.org/10.1016/j.cmi.2025.09.023

^[2] Tamiflu (Oseltamivir) - Roche. Xofluza (Baloxavir) - Shionogi, Roche. H5N1 bird flu viruses resistant to Oseltamivir have already occurred. Resistance to Xofluza occurred at a high frequency in its clinical trial.

^[3] Influenza viruses generate variants by more mechanisms than most viruses: (a) by mutations, typically few and small changes in viral proteins; (b) by recombinations, wherein portions of its genomic strands are swapped between the strands derived from two different Influenza A viruses infecting the same cell; (c) by re-assortments, wherein entire genomic segment from one Influenza A virus is packaged into a different Influenza A virus in the same cell. Each complete Influenza A virus contains eight separate genomic RNA strands, giving it tremendous flexibility for "swapping" these segments and generating new variants. It is thought that all influenza A viruses causing outbreaks or pandemics among humans since the 1900s originated from strains circulating in wild aquatic birds through reassortment with other influenza strains (wikipedia, https://en.wikipedia.org/wiki/Influenza_A_virus).

^[4] All Influenza viruses bind to HSPG (heparan sulfate proteoglycan) as the first "attachment receptor", and thus are targeted by the drug NV-387. The viruses then gain proximity to cells, and latch onto the Sialylated glycoproteins on the cell surface which is called the "cognate receptor" that enables the virus to be taken inside the cell. The cognate receptor for Influenza viruses that remain infectious to birds is slightly different from the one that the virus would need to use for efficiently infecting human cells. However, just one or a few mutations would be required in the currently circulating H5N1 bird flu viruses to become efficient in human-to-human transmission. Two different clades of H5N1 are circulating, one in wild birds, infecting into poultry, and another in dairy cattle, infecting pets and animals that drink raw milk, bringing the threat closer to a potential pandemic than it has ever been since the late 1990s.

SOURCE: NanoViricides

View the original press release on ACCESS Newswire

(B.Smith--TAG)