NanoViricides Inc. (NYSE American: NNVC) Begins Long-Awaited Clinical Trials For Its Anti-Viral Nanomedicine NV-CoV-2, Oral, Amid Continuing Need For COVID Treatment
By David Willey, Benzinga
NanoViricides (NYSE American: NNVC) is a drug development company working on a novel nanomedical treatment. It recently updated the world on the status of its long-awaited and now active trials into its lead drug candidate, NV-CoV-2.
NV-CoV-2, the Companys lead drug candidate for the treatment of coronavirus infections including COVID and potentially many cases of long COVID, has entered human clinical trials initiated by the Drug Sponsor Karveer Meditech Pvt. Ltd. India, the Companys Licensee and co-developer in India, announced the Company.
NanoViricides is developing cutting-edge nanomedicine treatments, which use their special nanomicelles ability to directly attack and destroy the virus particles. To do this, the nanoviricides mimick the receptor site on the cell to which the virus binds. No matter how many variants develop, this site remains the same, so the virus is unlikely to escape the nanoviricide drug.
The Companys drug candidate NV-CoV-2 uses the companys patented nanoviricide platform technology, which uses novel mechanisms to fight COVID-19 and potentially all other human coronaviruses.
The Need For A Lasting Coronavirus Treatment
As the company races to develop its leading drug, there remains a significant need to develop safe and lasting treatments for COVID-19 and other coronaviruses.
It has been estimated that by the end of the four-year period from January 2020 to December 2023, the COVID-19 pandemic will have cost the American economy up to $14 trillion.
Furthermore, it is estimated that 65 million people still suffer from long COVID, the continuation of coronavirus symptoms for months after clinically the infection itself has subsided. Symptoms of long Covid can range from mild to severe, and the case numbers of those with long Covid are continuing to increase.
Could NV-CoV-2 Be Used For Future Pandemics?
Then there are the risks of other coronaviruses and future pandemics. A prediction from the disease research group Metabiota, says that there is a 47% – 57% likelihood that another pandemic as serious as COVID-19 could occur within the next 25 years.
This is why NanoViricides believes it is important to develop a drug that is safe and effective for treating a wide range of patients. Its drug candidate NV-CoV-2 has oral formulations for milder cases and an injectable solution for more severe patients. The company is focusing its attention on treatment for COVID-19 for now, but the innovative nanomedicine could even be a broad-spectrum antiviral for treating diseases beyond COVID-19.
We believe these clinical trials are an important milestone not only for NanoViricides and Karveer Meditech, India, but also for the advancement of treatments against all viral infections worldwide, said Dr. Anil Diwan, Ph.D., President and Executive Chairman of the Company, explaining, NV-CoV-2 is aimed at satisfying the as-yet-unmet medical need of a highly effective broad-spectrum, anti-coronavirus drug that can be used for all patient populations. Moreover, it brings into the clinic a novel platform technology of attacking viruses to develop highly effective antiviral drugs.
Treatments for COVID-19 currently on the market include Molnupiravir from Merck & Co. (NYSE: MRK), Paxlovid from Pfizer Inc. (NYSE: PFE) and Remdesivir from Gilead Sciences, Inc. (NASDAQ: GILD), though there are problems or limitations with each of these options, and the multi-billion-dollar market remains wide open for a new effective treatment. The overall antiviral market is projected to surpass around $71.1 billion by 2032.
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-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, we are developing a clinical candidate for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. The Company cannot project an exact date for filing an IND for this drug because of its dependence on a number of external collaborators and consultants.The Company is now working on tasks for completing an IND application. The Company is currently pursuing two separate drug candidates for the treatment of COVID-19 patients. NV-CoV-2 is our nanoviricide drug candidate that does not encapsulate Remdesivir. NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2 with Remdesivir encapsulated in it. 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 intends to re-engage into an IND application to the US FDA for NV-HHV-101 drug candidate for the treatment of shingles once its COVID-19 project moves into clinical trials, based on resources availability. The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization for COVID-19 drug development work.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 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.
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