SHELTON -
NV-387 is currently in Phase 1a/1b human clinical trials for COVID-19 indication in
We believe that this broad-spectrum antiviral activity of NV-387 is observed because NV-387 is designed to mimic a host cell membrane bearing Sulfated Proteoglycans ( S-PG ) family of virus attachment receptors. S-PG receptors taken together are involved in the re-infection lifecycle of more than 90% of human pathogenic viruses.
Thus, we believe that NV-387 has a broad spectrum of antiviral activity that is reminiscent of the antibacterial activity of antibiotics. We believe that the Nanoviricides Platform Technology is poised to revolutionize the fight against viruses just as antibiotics revolutionized the fight against bacterial infections.
Tecovirimat ( TPOXX ,
We believe that non-dilutive government funding may be possible for the development of a NV-387-based drug for the treatment of Smallpox and Mpox, given these excellent results, said
Smallpox-causing Variola virus is considered a significant biodefense threat. While smallpox vaccines are available, their general public health usage has stopped after Smallpox was declared eradicated in 1980, leaving persons under the age of about 45 vulnerable.
Tecovirimat is stockpiled by the
There is significant interest in the development of a smallpox therapeutic drug that works well by itself, as well as in combination with the known drug, Tecovirimat. Tecovirimat has a low barrier of escape; a single mutation in one protein can enable the virus to escape this drug, adding to the significance of additional smallpox drug development.
Since human clinical trials are not feasible for the deadly Variola virus, infection of the related animal viruses in their native species is used for evaluation of drug effectiveness under the FDA Animal Rule . Variola (Humans), Mpox (Monkeys), Ectromelia (Mice), and Rabbitpox (Rabbits) are some of the closely related pathogenic viruses belonging to the Orthopoxvirus genus (with their native hosts listed in parentheses).
The animal-rule based efficacy studies conducted under GLP conditions substitute for the usual Phase 2/3 human clinical efficacy trials for regulatory approval under the Animal Rule. Additional human safety clinical studies are expected to be required. This pathway may enable rapid regulatory development of NV-387 as a smallpox therapeutic towards approval.
Previously, the Company has reported that NV-387 was highly effective for the treatment of lethal lung infection by the Respiratory Syncytial Virus (RSV). Currently there is no approved treatment for RSV other than ribavirin which is only conditionally approved only for patients with high risk of progressively severe RSV disease, due to significant side effects including hemolytic anemia and kidney failure.
RSV therapeutics is estimated to be a multi-billion-dollar market, as we have previously reported.
We believe that NV-387 works by a novel mechanism of action, that of blocking the re-infection lifecycle of the virus. We believe that NV-387 not only binds to the virus, but fuses with the virus surface, uprooting the glycoproteins that are required for the virus to bind to the human cell (for example, the S protein, and its products S1 and S2 proteins for coronaviruses), thereby rendering the virus incapable of infecting a cell. In contrast, antibodies are only capable of incompletely decorating the virus.
We believe that NV-387 mimics the Sulfated Proteoglycans ( S-PG ) family of virus attachment receptors. This family includes heparan sulfate (HSPG), dermatan sulfate (DSPG), chondroitin sulfate (CSPG), and keratan sulfate (KSPG). Over 90% of known pathogenic viruses bind to one or more of these S-PG class attachment receptors. These viruses include Coronaviruses, Paramyxoviruses (RSV - Respiratory Syncytial Virus, and HMPV- human Metapneumovirus), Dengue Viruses, Herpesviruses, Human Papillomavirus (HPV), HIV, Hendra and Nipah Viruses, Ebola and Marburg Viruses, Poxviruses, among others.
We believe that the successes of NV-387 as a broad-spectrum antiviral bode well for validating the multiple modalities in which our Nanoviricides Platform Technology can be employed to revolutionize the treatment of viral infections as well as pandemic preparedness response.
We have found that NV-387 is highly active against tested coronaviruses including SARS-CoV-2 in pre-clinical studies. We are continuing to expand our pre-clinical studies to evaluate the antiviral activity of NV-387 against other viruses. We believe that this work would expand the range of indications for NV-387. Such expansion of use of NV-387 would significantly expand the market size and substantially improve the return on investments (ROI).
NV-387 is in Phase 1 human clinical trial as two oral formulations: (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies in
What is a nanoviricide
A nanoviricide is a uniform polymer that self-assembles into nanoscale droplets called micelles , that carries on its surface mimics of the cell-side receptor of the virus, and that hides in its belly lipid tentacles. It can also hold other guest APIs in its belly if needed. The nanoviricide thus looks like a cell to the virus, and the virus is fooled into binding it. Once the virus binds, we believe, the flexible and shape-shifting nanoviricide micelle would spread over the virus particle by virtue of merging the lipid tentacles that are hidden in its belly into the virus surface, in a well known process called lipid-lipid mixing. We believe this would destabilize the virus particle, uproot the viral glycoproteins required for binding to and entering the host cell, and thus render the virus particle incapable of infecting a cell.
About
NV-CoV-2 is our nanoviricide drug candidate for COVID-19 containing the nanoviricide
NV-CoV-2 does not contain 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
The Company is also developing drugs against a number of viral diseases including RSV, 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
MJ Clyburn
Email: clyburn@tradigitalir.com
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