Financial Status - Sufficient Funds to Conduct Clinical Trial
We reported that, as of
On
NanoViricides Platform Technology and Drug Pipeline
We have several drugs in our pipeline. Our lead clinical stage drug is NV-CoV-2 for the treatment of COVID and potentially the residual virus cases of 'long COVID'. It is in Phase 1a/1b human clinical trials in
NV-387, our broad-spectrum antiviral nanoviricide agent, is the active ingredient in NV-CoV-2. It has demonstrated significantly superior effectiveness compared to remdesivir, an approved COVID drug, in an animal model of lethal hCoV-NL63 infection that simulates severe COVID-19 with lung disease.
We have found that NV-387 is also effective against RSV infection in an animal model, matching the effectiveness of the last-resort toxic drug ribavirin. Additionally, subsequent to the quarterly reporting period, yesterday we reported that NV-387 was found to be as effective as the approved drug tecovirimat (TPOXX, SIGA) in an animal model that is used for drug development for Smallpox and Mpox infections.
While COVID pandemic is waning with a decreased severity from SARS-CoV-2 infections, 'long COVID' cases continue and the potential of a more pathogenic variant arising cannot be overstated. In addition, due to the significant limitations of available therapeutics (namely Paxlovid,
A safe and effective antiviral drug with such an extensive broad-spectrum activity across virus families as presented by NV-387 is an unmet medical need. This development is akin to the development of antibiotics to treat bacterial infections and could be as revolutionary towards the treatment of viral infections.
The market size for COVID drugs is expected to continue to be in the billions of dollars range. The market size of an RSV therapeutic is estimated to be several billions of dollars. Although smallpox therapeutics are limited to government stockpiling, the market size for an effective smallpox therapeutic is estimated to be in the order of several hundred million dollars a year.
We believe that upon completion of the Phase 1a/1b human clinical trials of NV-CoV-2, the NV-387 oral formulations may be eligible for Phase II/III clinical trials for RSV. There is no therapeutic available for RSV other than the last resort option of Ribavirin.
We anticipate that NV-387 formulations would be expected to be eligible for the development of Poxvirus therapeutics under the FDA 'Animal Rule,' if further studies are successful. The Animal Rule regulatory pathway requires GLP studies in specific animal poxvirus infection models as replacement of the Phase II/III human clinical trials, and expanded Phase I human clinical trials to elucidate safety of the drug in human use. We plan to seek non-dilutive government funding for this indication.
NV-387 has such broad-spectrum activity because it is designed to mimic the attachment receptors to which over 90% of viruses bind before infecting a cell. We are currently engaged in expanding the spectrum of activity of NV-387. NV-387 is an example of NanoViricides Platform Modality #1 implementation.
NanoViricides Platform Technology has an important advantage in that no matter how much a virus changes in the field, it is unlikely to escape the nanoviricide drug because it is designed to mimic the very features that the virus uses to bind to and enter cells. These specific molecular signature features on the cellular side do not change even as the virus mutates, and nanoviricides are designed to mimic these features. In contrast, viruses readily escape antibodies as drugs, as well as vaccine-induced immunity as they evolve in the field, as is well known from the COVID-19 pandemic as well as Influenza pandemics and the continuing HIV/AIDS pandemic.
A safe and effective antiviral drug that the virus would not escape by simple mutations or field evolution is the holy grail of antiviral drug development. We believe that the NanoViricides Platform technology meets this challenge.
We have previously developed NV-HHV-1 as a skin cream formulation for the treatment of Shingles rash caused by the Varicella Zoster Virus (VZV) that also causes Chickenpox in children and immune-compromised adults. We plan on advancing NV-HHV-1 into clinical trials after advancing the NV-387 based drug programs into clinical trials. This drug mimics HVEM, a receptor used by herpesviruses. We plan on further development of our other drugs in the HerpeCide Program as we begin to advance NV-HHV-1 further into regulatory pathway.
About
NV-CoV-2 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-CoV-2 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already
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.
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
Contact:
Email: info@nanoviricides.com
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