SHELTON, CT / ACCESSWIRE / August 19, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage global leader in broad-spectrum antiviral nanomedicines, is providing an update on its clinical program activities.
Dr. Anil Diwan, the Company's President, and Executive Chairman, is currently visiting with various expert professionals with the objective of developing a Phase II clinical trial plan and corresponding clinical protocol for a Phase II clinical trial of the drug candidate NV-387. The Company believes NV-387 is poised to become a revolutionary broad-spectrum antiviral treatment for infections from a number of viruses including RSV, COVID, and Influenzas, based on several animal studies.
Just three of the viruses addressed by this single drug NV-387, namely, Influenza, RSV and COVID, account for over $8 Billion in estimated market size in 2024, growing to an estimated $12 Billion in three years, as calculated by the Company from various market reports.
A successful Phase II clinical trial is expected to provide results demonstrating a strong effectiveness of NV-387 against different human pathogenic viruses, consistent with the strong effectiveness parameters found for NV-387 treatment of lethal virus challenge in various non-clinical animal model studies for RSV, COVID, Influenza, as well as Smallpox/Mpox.
With advice and opinions of experts, the Company is exploring the design of an innovative and ambitious, adaptive Phase II clinical trial wherein the effectiveness of the single drug NV-387 can be assessed for the treatment of a number of naturally occurring virus infections in humans in a single clinical trial.
In particular, the Company plans on exploring the effectiveness of NV-387 for the treatment of Severe Acute Respiratory Infections caused by Viruses ("SARI-Viral"). Most of such infections are caused by Influenza, RSV, and Coronaviruses, with a small extent of such infections being caused by other viruses including Adenoviruses, hMPV, and others.
If successful in such a clinical trial, NV-387 could become the very first drug that could be indicated as a first line treatment of any respiratory viral infections without having to wait for the results of testing for the type of virus, in a manner similar to how antibiotics can be prescribed by physicians at present.
"We are already preparing for a novel Phase II clinical trial design to evaluate the effectiveness of NV-387 against RSV, Influenza, and COVID in a single clinical trial," said Dr. Diwan, adding, "Such a clinical trial design would save substantially on the costs of development, improve return on investment, as well as open new avenues of how to treat a respiratory viral infection for physicians, thereby defining a new chapter in humanity's fight against viruses and pandemics."
It is well known that early treatment of a viral infection improves chances of success, but the need for testing for the type of infecting virus in order to select appropriate treatment necessarily introduces a delay in the treatment. Development of NV-387 as a broad-spectrum antiviral that addresses most respiratory viral infections is expected to eliminate this need for testing and thus the corresponding delay thereby enabling immediate treatment and improving success rates. This novel paradigm for treating viral infections enabled by the broad-spectrum nature of NV-387 would be similar to the current practice for most bacterial infections that can be immediately treated with a broad-spectrum antibiotic.
NV-387 has recently completed a Phase I clinical trial for the evaluation of safety and tolerability in healthy volunteers. The data analysis from this clinical trial is expected to begin soon. We have previously reported on the basis of clinical observations that NV-387 was found to be well tolerated in this clinical trial at all dosage levels.
The Company notes that the idea of such a Phase II trial design originated from physicians actively treating patients, and that this idea has been received enthusiastically by several experts in both medical and regulatory domains. The Company further notes that any such novel Phase II clinical trial design as we are envisaging would require regulatory approval from appropriate regulatory authorities prior to executing it.
NV-387 is designed to mimic a host-side feature that over 90% of human pathogens use in the process of infecting cells, called sulfated proteoglycans ("S-PG"). We believe that this design has enabled the broad-spectrum antiviral effectiveness of NV-387 as observed in a number of lethal virus challenge infection animal studies.
A virus would not be able to escape the nanoviricide drug NV-387 even as the virus evolves, we believe, because, despite the multiple changes in it, the virus continues to use the same host-side feature for successful infection. This potential lack of viral escape expected for NV-387 is unlike most, if not all, current antiviral medical countermeasures (MCMs), including vaccines, antibodies, and small chemical drugs. Viruses readily escape the current MCMs as the viruses evolve in the field, which has now become general knowledge with the experience from recent pandemics.
The Company has already found that NV-387 was superior to or equivalent to existing drugs in non-clinical animal trials in the case of three major classes of viruses: RSV, Influenza, and COVID; the so-called "triple-demic" respiratory viruses - and even orthopoxviruses (Smallpox/Mpox). These animal studies have laid the foundation for the innovative Phase II clinical trial design that came about in discussions with physicians.
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-387 for the treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections. Our other advanced 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 poxviruses and/or enteroviruses 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.
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".
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SOURCE: NanoViricides, Inc.