By David Willey, Benzinga
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Effective treatments for COVID-19 remain very few and very limited in their capabilities, even after three years. As a result, there are still high rates of hospitalizations and COVID remains many times more deadly than influenza. A pan-coronavirus drug that is safe enough to be used by anyone and is highly effective remains an unmet medical need.
NanoViricides Inc. (NYSEAMERICAN: NNVC), a leading biopharmaceutical company developing nanotechnology-based antiviral therapeutics, has been working on a pan-coronavirus antiviral to fulfill this unmet medical need. The company has been a drug discovery company for many years while it has looked to perfect its patented nanoviricide technology, a platform technology that deploys a novel mechanism to combat viruses. With this unique technology, the Company has reported developing a strong R&D pipeline of many antiviral drugs.
NanoViricides is now excited to be transitioning into becoming a clinical-stage pharmaceutical company, and with a drug against COVID. The clinical trials of NV-CoV-2, the Company’s pan-coronavirus drug, are now imminent. The drug has already successfully completed the preclinical safety and effectiveness studies, and the Company has already set up cGMP manufacturing for the clinical drug products.
NanoViricides Drug To Work Against All Current and Future COVID Variants?
NV-CoV-2 is a broad-spectrum antiviral that looks to treat most human coronaviruses and will maintain its effectiveness as the variants mutate. This may mark a major step in the fight to find a permanent solution to COVID. Developing a drug that works against multiple COVID variants is key because as each variant mutates and spreads it has the risk of further widespread outbreaks causing an endemic or even a future pandemic.
Despite the rollout of the vaccine from companies including Novavax Inc. (NASDAQ: NVAX), Moderna Inc. (NASDAQ: MRNA), AstraZeneca (NASDAQ: AZN), and Pfizer Inc. (NYSE: PFE), there are still over 170,000 infections weekly, as well as close to 3,000 hospitalizations and 1,800 deaths in the USA alone. COVID is still the biggest viral public health threat today.
In the ongoing fight against the virus, one major battle is of coping with the multiple coronaviruses and the continuous evolution of their variants. In addition to SARS-CoV-2 and its variants, there are already four known seasonal human coronaviruses, hCoV-229E, hCoV-OC43, hCoV-HKU1, and hCoV-NL63, with NL63 causing the most similar symptoms to SARS-CoV-2. Any of these can lead to a more pathogenic variant in the near future. As these viruses continue to mutate, they render antibodies developed against previous strains ineffective. This means even so-called “hybrid immunity”– natural protection combined with vaccination – often only lasts for around eight months.
It is important to note that all of the antibody drugs that were given emergency use authorizations (EUAs) have had the EUAs revoked upon becoming ineffective.
NV-CoV-2 was found to work against many unrelated coronaviruses. So variants of SARS-CoV-2 (that causes COVID) are highly unlikely to be able to escape it.
NanoViricides Drug NV-CoV-2 Could Cater To The Needs of All Patients
Antiviral medication is an important way of coping with viral infections, other than vaccines and antibodies, as we all know from HIV. These drugs help the body fight off infection at the cellular level. However, there are significant issues with the antivirals currently on the market for
treating COVID. These include Molnupiravir from Merck & Co. (NYSE: MRK), Paxlovid from Pfizer Inc. (NYSE: PFE) and Remdesivir from Gilead Sciences, Inc. (NASDAQ: GILD), which either have limited effectiveness in treating the disease or carry the risk of serious side effects or both. Of note, they all have significant limitations on which category of patients can be helped.
Unlike the existing COVID drugs, NanoViricides’ drug NV-CoV-2 caters to the needs of all patients. The Company has developed oral syrup and oral gummies for use in mild to moderate disease (out-patients). It has developed an injectable solution that can be injected, inhaled or infused, for use in severely ill or hospitalized patients. Having these multiple formulations gives the drug a broad range of applications; it would be available to patients with or without comorbidities and patients of all ages from a child to an octa(+)genarian. This unmatched useability is driven by its demonstrated strong safety and effectiveness in preclinical studies.
The company also has the ability to manufacture clinical quantities of the drug products for clinical trials in its own “current Good Manufacturing Practices (cGMP)”-compliant facility, enabling time and cost savings.
NanoViricides At An Inflection Point In Its Lifecycle?
The company’s clinical trials could be ground-breaking — a novel anti-coronavirus drug, and the possibility for the trials to also prove that the Company’s platform is indeed capable of delivering clinical drugs. There is a whole pipeline of preclinical drugs that the Company intends to advance further.
The global antiviral market was worth $48.1 billion in 2018 and is expected to grow to $79.8 billion at a compound annual growth rate (CAGR) of 6.7% from 2019 to 2026.
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This article was originally published on Benzinga here.
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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