This season, two different genotypes of H5N1 bird flu, namely (a) the severe and lethal form D1.1 that has spread globally in birds, and (b) the less severe B3.13 genotype widely spread in diary cattle in North America are causing major concerns even as Seasonal Influenza cases abound.
In addition to that, in the USA, and globally, there are significant numbers of cases of COVID-19, RSV, and hMPV as expected seasonally, that cause various respiratory syndromes from common colds to bronchitis to pneumonia. Norovirus, a primarily gastro-enteric infection that causes vomiting and severe diarrhea has surged up as well.
All of these are RNA viruses that evolve rapidly in the field. All of these can develop resistance to vaccines, antibodies, and existing small chemical drugs (if any) soon after they face such countermeasures in the field.
This is because the resistant virus species that develop in a patient survive and thereafter infect new hosts, thereby proliferating and spreading further, as we have witnessed repeatedly during the COVID-19 pandemic.
Developing specific vaccines and antibodies against each virus strain of each virus type as it evolves in the field is untenable and has poor economic and public health benefits that are short-lived at best [1] .
The situation is clearly crying out for the world to look for new approaches for pandemic preparedness. Obviously, when people get sick the patients need effective treatments that the virus cannot escape even as the virus evolves.
We believe the incoming Administration understands this well, as is evident from President Trump's push for effective therapeutics during the COVID-19 pandemic in his last term.
In this scenario, NV-387 stands apart in the field of antiviral countermeasures in that escape of virus even as it evolves is highly unlikely. This is because (i) NV-387 mimics the essential host-side feature that the virus requires for causing infection, and (ii) the activity spectrum of NV-387 is so broad, encompassing not just a type of virus, but across many different types of viruses, that any small changes in a virus would be unlikely to enable the virus to escape NV-387.
NV-387 was found to have substantially superior activity against a lethal Influenza A H3N2 virus infection in animal model, in comparison to oseltamivir (Tamiflu), peramivir (Rapivab), as well as baloxavir (Xofluza). it is known that each of these existing drugs can be escaped by single-point mutations by the influenza virus.
NV-387 was found to be substantially superior to remdesivir in lethal coronavirus infection animal models.
NV-387 was found to be equivalent or superior to tecovirimat in lethal orthopoxvirus infection animal models. We believe these data should enable Phase II clinical trial of NV-387 for the treatment of Clade 1/1b MPOX in the current epidemic in the African Region.
NV-387 was found to cure lethal RSV infection in animal models. There is no other effective drug for treatment of RSV infection.
Additionally, hMPV is a close cousin of RSV and uses the common human receptor, HSPG, to establish infection. We therefore expect NV-387 to be successful as a treatment for hMPV infections.
Thus NV-387 has emerged as a single drug that can combat literally all of the current viral threats going around as well as those on the horizon. NanoViricides is committed to its further clinical development in the most rapid fashion.
Importantly, the H5N1 bird flu virus from wild birds is rapidly evolving as it is contracted by humans; this is now established. Mutations were found in H5 gene that clearly indicate that the virus can readily escape vaccines and antibody drugs. Other mutations indicate the virus could acquire resistance to existing drugs rapidly, although in the Canadian girl's case, no evidence of reduced antiviral susceptibility was found.
The first fatality from H5N1 Bird Flu in the USA was announced on January 6, 2025 - an elderly Louisiana person with existing medical issues who died after fighting the virus for at least 20 days in the hospital. Just before this, a Canadian teenager girl survived a severe H5N1 infection suffering for almost 30 days with over 20 days in the hospital. In both cases, the virus was Influenza A H5N1 genotype D1.1 which is globally distributed in wild birds, and in open range bird flocks. Both cases were thought to have acquired infection from birds in the field.
In both cases, mutations in the H5 protein of the virus were found that increased the virus' ability to target the human receptor (E186D, Q222H, A134V, N182K).
This high propensity towards mutations in H5 would render vaccines and antibodies ineffective.
Additional mutations were also found in other important genes that can lead to greater pathology as well as resistance to current small chemical drugs.
Widespread H5N1 infection in dairy cows led California to declare a bird flu emergency in December. This virus is different from the one that caused the fatality, and is classified as Influenza A H5N1 genotype B3.13. The dairy cow H5N1 has infected over 60 persons, but has caused milder disease than the genotype D1.1.
Across the pond, in China, an epidemic of another respiratory virus, hMPV, has begun, and has already spread to several neighboring countries. This virus usually causes cough and colds that are not very severe, but in the current scenario, it is causing severe respiratory disease in children, older adults, and immunocompromised persons. hMPV is closely related to RSV and both are known to use HSPG to establish infection.
There is no drug or vaccine for the treatment of hMPV infection. Two vaccines are available for adults for RSV. There is no effective drug for the treatment of pediatric patients.
NV-387 mimics HSPG and was found to cure lethal RSV infection in animal model. Thus we expect NV-387 to be active against hMPV as well.
New viruses and existing viruses acquiring greater pathology and infectivity are bound to keep appearing in time. To combat such threats, we need to develop broad-spectrum drug arsenal that the viruses cannot escape. Vaccines and antibodies simply will not do, as their limitations have become clearly evident during the COVID-19 pandemic.
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.
info@nanoviricides.com
Public Relations Contact:
ir@nanoviricides.com
[1] To begin with, at least 2 H5N1 vaccines, and 1 hMPV vaccine, would be required right away in the current scenario. These as well as already existing vaccines against 3 Influenza seasonal strains, the COVID vaccines, all will need to be updated regularly in case a fast-moving pandemic occurs. As a new vaccine is distributed, already the viral strains would have moved on; it is a chase that never hits the target. Add to the vaccine development costs also the costs of deep cold storage, deployment, distribution and administration of the vaccines.
In spite of all this, the threshold level of vaccination required to stop a pandemic cannot be met because of resistance of people, mistrust, as well as known and unknown side effects. Vaccinations do have benefits of reducing hospital load and possibly also overall fatality rates. However, long-lasting immunity against these viruses is not found to result unlike other well-established vaccines.
Contrast this with the costs of developing and stock-piling just a small number of broad-spectrum nanoviricide antiviral drugs that together can capture almost any known and unknown viral threats! Further, nanoviricides are orally available drugs, and stable in storage at room temperature.
SOURCE: NanoViricides
