With Rising Variants of COVID and Bird Flu, the Single Broad-Spectrum Antiviral NV-387 Would be the Best Partner for Preparedness, Says NanoViricides' Dr. Diwan
Nimbus, a new COVID variant, officially NB1.8.1, is displacing the LP8.1 variant that was dominant until a few weeks ago in the USA (https://www.today.com/health/coronavirus/new-covid-variant-nb181-nimbus-symptoms-rcna212304).
Nimbus has been rising globally since Spring according to WHO (https://cdn.who.int/media/docs/default-source/documents/epp/tracking-sars-cov-2/23052025_nb.1.8.1_ire.pdf).
Nimbus causes 'razor-sharp' sore throat in some individuals, which is extremely painful and lingering for some time, in addition to the usual COVID symptoms.
Nimbus is more resistant to antibodies generated from previous vaccines, although prior vaccination or natural COVID infection is expected to still be protective in terms reduced severity compared to without such immunity according to CDC.
Nimbus is likely to be more transmissible than the previous variants. It belongs to the JN.1 subfamily of the Omicron family of SARS-CoV-2 virus.
Recently, the Influenza A H5N1 virus from a dairy worker in Michigan was found to be capable of airborne transmission in a ferret animal model [1] (https://www.freep.com/story/news/health/2025/06/05/h5n1-bird-flu-michigan-dairy-farm-airborne-spread-cdc-study/84046550007/). This genotype B3.13 (clade clade 2.3.4.4b) virus in dairy cattle causes moderate severity disease in humans. In contrast, a highly pathogenic genotype D1.1 that is circulating in birds birds has led to one critical month-long illness in Canada and one death in the US signifying the potential for high morbidity and mortality from this genotype if it spreads in humans.
Additionally, a new genotype of H5N1 in Cambodia has caused four fatalities and fifth severe infection as of today (https://www.cidrap.umn.edu/avian-influenza-bird-flu/h5n1-avian-flu-infects-fifth-patient-cambodia).
NV-387, the broad-spectrum antiviral drug is expected to be effective against all of these bird flu viruses. NV-387 was found to be substantially superior to Tamiflu® (Roche, Oseltamivir), Rapivab® (Biocryst, Peramivir), as well as Xofluza (Shionogi/Roche, baloxavir) in lethal lung infection animal model of Influenza infection. All three of these existing anti-influenza drugs are known to be escaped by Influenza viruses by single point mutations in H or PB2 genes.
NV-387 was found to be substantially superior to the approved drug Remdesivir in a lethal coronavirus lung infection animal model for SARS-CoV-2.
Thus the single drug NV-387 alone can combat H5N1, Influenza as well as COVID infections.
NV-387 has completed Phase I clinical trial in healthy human subjects with no reported adverse events.
COVID as well as Influenza viruses readily escape vaccines, antibodies as they change in the field during an epidemic wave. They are also likely to escape small molecule drugs by such changes.
NV-387 takes advantage of the invariant features that these viruses use for causing infection, by mimicking heparan sulfate-like structures. No matter how much these viruses change in the field, they continue to use the heparan sulfate attachment receptors in order to cause infection. Thus it is practically impossible that the viruses may be able escape NV-387 without losing their ability infect and transmit across humans, the Company believes.
NV-387 is orally available, formulated as oral gummies that dissolve in the mouth, thus avoiding issues of inability to swallow which occurs related to sore throat, old age, as well as in young children.
NV-387, as a treatment, is designed to help actually patients with disease recover rapidly, thus limiting the viral spread as well as providing for natural infection-based immunity in the recovered patient.
'NV-387 is thus the best current choice available for a highly cost-effective pandemic preparedness development,' said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, 'We have US-based cGMP manufacturing capabilities already set up as well.'
Of note, natural immunity, as induced by recovery from infection, is known to be superior to immunity from subunit and mRNA vaccines. One of the important reasons is that in natural infection, the immune system is subjected to all possible antigens from the entire virus, unlike just the selected antigens or antigen fragments that are present in subunit or mRNA vaccines.
Also, NV-387 can be manufactured in the USA and stockpiled readily at room temperature or refrigeration (for longer periods of time).
Unlike NV-387, vaccines or antibodies would require to be created after the virus takes hold, and they would suffer substantial loss of effectiveness within months after deployment due to changes in the virus. Additionally, vaccines require a cold chain handling. Vaccines also need to be administered to a large proportion of healthy population. There are significant logistical problems with vaccines. There is also the issue of vaccine reluctance, which is a personal choice, as it should be in a free country like the USA.
The broad-spectrum antiviral drug NV-387 was developed specifically to overcome all of these problems. In case of further spread of a severe COVID variant and also a Bird Flu variant in human populations, it will be possible to move NV-387 rapidly into Phase II clinical trial for these diseases, and then prepare for deployment early in the potential pandemic, curtailing its spread.
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.
[1] Brock N, Pulit-Penaloza JA, Belser JA, et al. Avian Influenza A(H5N1) Isolated from Dairy Farm Worker, Michigan, USA. Emerging Infectious Diseases. 2025;31(6):1253-1256. doi:10.3201/eid3106.250386.
SOURCE: NanoViricides, Inc.
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