NanoViricides Explains Its Drug Strategy for Combating Viral Infections and Pandemics
SHELTON, CT / ACCESS Newswire / May 14, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the “Company”), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, explains its drug development strategy to combat important global viral threats.
Measles outbreaks have continued to expand in the US, and the dramatic ten-fold increase in annual Measles cases in Europe last year indicates that Measles will be here to stay. Measles vaccine failure cases have also been increasing according to the European data, which is an important cause for concern. Vaccination rates are falling in developed countries.
In this global scenario, NV-387, the clinical stage broad-spectrum, host-mimetic antiviral nanomedicine drug could perhaps be the only currently available drug candidate to combat the Measles virus and disease. There is no approved drug for Measles virus infection.
The Company has already initiated the process for conducting an animal efficacy study that would provide an answer to how effective NV-387 would be against Measles virus.
The Company will make NV-387 available to any licensed physicians intending to treat Measles cases under the Individual Patient Expanded Access protocol of the US FDA. The Company has its own cGMP manufacturing facility.
The Company is pleased to state that it is moving forward with the Phase II Clinical Trial Application (CTA) for the evaluation of NV-387 as treatment of MPox in the Domestic Republic of Congo (DRC). The National Ethics Committee of DRC has recently cleared NV-387 as a potential drug candidate that should advance into the clinical trial, enabling the CTA.
MPox is endemic in DRC, and has continued to cause large numbers of cases in the WHO African Region. In April, 2025, the WHO has restated that MPox continues to be a Public Health Emergency of International Concern (PHEIC), a designation it first declared for the MPox epidemic in August, 2024.
This PHEIC is driven by MPox Clade 1a and 1b viruses that are highly pathogenic and highly transmissible. A milder version, MPox Clade 2, caused an epidemic in 2022, and since then became endemic, in certain subsets of populations in the Western World. It is thought that MPox Clade 1a/1b viruses could possibly lead to a wider epidemic including the rest of the world beyond Africa.
There is currently no approved drug for the treatment of MPox infection. A drug, tecovirimat, (TPOXX®, SIGA) failed in clinical trials for the treatment of MPox. TPOXX has been approved for Smallpox in the USA under the FDA “Animal Rule” and continues to be stockpiled by the US Strategic National Stockpile. A broad-spectrum antiviral effective against all orthopoxviruses including MPox and Smallpox is needed.
“NV-387 is a revolutionary antiviral drug that can combat many viral infections,” said Anil R. Diwan, PhD, President and Executive Chairman of the Company, “We are advancing it rapidly towards establishing human clinical effectiveness data and regulatory approvals. We believe our MPox and Measles work will enable rapid advancement of the drug, and make a great global impact in large markets fulfilling unmet medical needs.”
The Company is also developing NV-387 as an “emperic” treatment of respiratory viral infections. We are developing a clinical protocol for a “basket-type” clinical trial, i.e. evaluating a single drug, namely, NV-387, against many viruses within a single clinical trial.
The focus of this proposed clinical trial will be on All Influenzas, All Coronaviruses, and RSV. If successful, this study would enable NV-387 to be prescribed immediately when a patient presents to the physician with a respiratory infection suspected to be viral, without waiting for test results to determine which viral infection it is.
Additionally, the Company is developing a pan-herpesvirus drug, NV-HHV-1. Herpesvirus infections from HSV-1, HSV-2, VZV, EBV, as well as HHV-6 have been linked to neurological damage that can eventually lead to Alzheimer’s disease. An effective drug that can eradicate herpesviruses is an unmet medical need. Such a drug can make a major impact on chronic diseases such as Alzheimer’s.
To date, only effective drugs have brought or maintained endemic or circulating viruses under control. There are no vaccines for herpes viruses, HIV or hepatitis C virus. Yet, successful drugs have helped patients to be cured (HCV), or recover from episodes (HSV), or at least maintain healthy lifespan (HIV) without any vaccines.
Market sizes for effective antiviral drugs run into several billions of dollars for each indication. Also, market sizes expand rapidly once an effective drug is introduced.
“NanoViricides is poised to revolutionize how we treat viral infections, just as antibiotics revolutionized treatment of bacterial infections,” said Dr. Diwan, adding, “We continue to march forward and strive hard to make this bright future a reality and to make a meaningful impact on public health, chronic diseases, and individual patients.”
Measles confirmed cases in the US have surpassed 1,000 already as of May 8th, 2025, across 31 jurisdictions, according to CDC report (https://www.cdc.gov/measles/data-research/index.html) .
Measles cases in Europe were over 35,000 in 2024, an almost ten-fold increase from 2023, according to the annual report of European Center for Disease Prevention and Control (ECDC). Only approximately 87% of cases were in unvaccinated persons, and 13% of the cases were of vaccine failure, out of the cases with known vaccination status.
The significant Measles vaccine failure rate observed in Europe is alarming, considering that the two-dose vaccine is supposed to be 97% effective. Overall, childhood vaccination was about 94% and declining. This rate is below the 95% considered the threshold for achieving “herd” or community immunity.
Given the various causes of vaccine failure, and of vaccine hesitancy, attaining 95% vaccine coverage cannot be considered a very probable solution to combating the Measles epidemic. An effective drug is needed to combat the epidemic.
NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) 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.
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.
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SOURCE: NanoViricides, Inc.
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