NanoViricides, Inc. (NYSE American:NNVC) (the “Company”) a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, today announced that it has nominated a clinical drug candidate for the treatment of COVID-19, thus further advancing its COVID-19 program closer to human clinical trials.
The Company has accelerated its drug development program for COVID-19 with the goal of creating the most effective medicine to obtain regulatory approval for emergency use in the COVID-19 pandemic in the shortest timeline feasible, after achieving proof of concept of broad-spectrum anti-coronavirus effectiveness of test candidates.
The Company therefore aggressively worked to harness the full power of the nanoviricides® nanomedicine platform to achieve these objectives.
A curative treatment for a virus such as SARS-CoV-2 coronavirus would require a multi-faceted attack that shuts down (i) ability of the virus to infect host cells and simultaneously, (ii) ability of the virus to multiply inside the host cells. The nanoviricide® platform enables direct multi-point attack on the virus that is designed to disable the virus and its ability to infect new cells. At the same time, a nanoviricide is also capable of carrying payload in its “belly” (inside the micelle) that can be chosen to affect the ability of the virus to replicate. The nanoviricide is designed to protect the payload from metabolism in circulation. Thus, the nanoviricide platform provides an important opportunity to develop a curative treatment against SARS-CoV-2, the cause of COVID-19 spectrum of pathologies.
The clinical candidate the Company has chosen is identified as NV-CoV-1-R. It is made up of a nanoviricide that we have found to possess broad-spectrum anti-coronavirus activity, now identified as NV-CoV-1, and remdesivir encapsulated inside the core of NV-CoV-1. NV-CoV-1 itself is designed to attack the virus particles themselves, and possibly would also attack infected cells that display the virus antigen S-protein, while sparing normal (uninfected) cells that do not display the S-protein. Additionally, remdesivir is widely understood to attack the replication cycle of the virus inside cells. Thus the combined attack enabled by NV-CoV-1-R on the virus could prove to be a cure for the infection and the disease, provided that the necessary dosage level can be attained without undue adverse effects. Human clinical trials will be required to determine the safety and effectiveness of NV-CoV-1-R.
Remdesivir is a well-known antiviral drug (developed by Gilead) that has been approved for emergency use treatment of SARS-CoV-2 infection or COVID-19 in several countries. NV-CoV-1 is a novel agent that is being used as an adjuvant to remdesivir in creating NV-CoV-1-R, to improve the overall effectiveness. It is well known that remdesivir suffers from rapid metabolism in circulation that breaks down the prodrug to its nucleoside form which is not readily phosphorylated. The Company anticipates that encapsulation in NV-CoV-1 may protect remdesivir from this rapid metabolism. If this happens, the effective level and stability of remdesivir in the body would increase. This increase may lead to increased effectiveness if there are no adverse effects. Such increased effectiveness, if found, may also allow reduction in the required dosage of remdesivir in the encapsulated form, i.e. as NV-CoV-1-R. In this sense, NV-CoV-1 can be viewed to act as an adjuvant that enhances the effect of remdesivir, a known antiviral against SARS-CoV-2.
“This is an extremely important milestone for the Company,” said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, “We look forward to rapid development of the IND enabling core safety pharmacology studies and, thereafter, human clinical development on an accelerated timeline in these trying times of the pandemic.”
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 have declared a clinical development candidate, namely NV-CoV-1-R, which encapsulates remdesivir inside NV-CoV-1, for the treatment of COVID-19. The Company cannot project an exact date for filing an IND for NV-CoV-1-R because of its dependence on a number of external collaborators and consultants.
The Company is now working on performing required safety pharmacology studies and completing an IND application for NV-CoV-1-R. The Company believes that since remdesivir already has an emergency use approval, NV-CoV-1-R is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed NV-CoV-1-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 and Ebola/Marburg viruses. The Company has executed a Memorandum of Understanding with TheraCour that provides a limited license for research and development for drugs against human coronaviruses.
The Company intends to obtain a full license and has begun the process for the same. 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.
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. FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. CMC refers to “Chemistry, Manufacture, and Controls”.