This Clinical-stage Biotech Company is Taking Its Revolutionary Platform to Help Eradicate Many Respiratory Viruses: a SINGLE drug treats RSV, FLU/Birdflu, long COVID…and even monkey-pox & measles!
NanoViricides, Inc. (NYSE American: NNVC) is a clinical-stage, global leader in broad-spectrum antiviral nanomedicines is developing therapeutic drugs that are safe and effective, even against variants, using a Revolutionary Platform Technology that does not rely on the host’s immune system. It’s lead drug NV-387 has completed Phase 1a & Phase 1b with no reported adverse effects, indicating excellent safety of Oral Syrup & Oral Gummies.
Lead drug, NV-387 addresses a $2.5 Billion to $4.3 Billion market:
- Since it is a potential cure for RSV infection, and since there is no non-toxic drug for general treatment of RSV infection at present; NV-387 meets an unmet need.
- A therapeutic for treating measles is a completely missing link in the response the the current measles virus outbreak; NV-387 could meet this unmet need too.
- The anti-Influenza activity of NV-387 given orally was substantially superior to all three of the approved anti-influenza drugs (Tamiflu, Rapivab, and Xofluza).
- Bird flu is rampant in poultry in the USA leading to hen culling and soaring egg prices, resulting in a race to find a treatment that works; NV-387 can address it.
- Long COVID also remains a problem for an estimated 17 million adults; an effective antiviral such as NV-387 has already delivered successful Phase 1 results.
- While smallpox is eradicated in the USA, contagious monkeypox has appeared but there is no effective drug treatment for it and competitors clinical trials have failed; NV-387 is entering Phase 2 clinical trials for it.
Download The Corporate Presentation
Nanoviricides CEO Dr Anil Diwan joined Steve Darling from Proactive to discuss the company's exploration of using its antiviral candidate, NV-387, for the treatment of MPOX patients under the World Health Organization's (WHO) MEURI protocol.
Watch the video
NV-387 - A novel broad-spectrum antiviral
NanoViricides, Inc. (NYSE American: NNVC)’s lead drug candidate NV-387 (drug product NV-CoV-2), a drug that treats RSV, COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections as well as Monkey-pox, has successfully completed Phase 1 clinical trials in healthy subjects with no reported adverse events, even at the highest and repeated dosages. Remarkably, NNVC has been able to develop NV-387 for oral administration already, as well as for injectable and inhalation formulations to enable many modes of use. The Company is currently focused on advancing NV-387 into Phase II human clinical trials for the treatment of RSV infection & monkeypox.
NanoViricides already has a clinical stage broad-spectrum antiviral drug NV-387 that may be effective for treating Measles infection. NV-387 was found to cure lethal RSV infection in an animal model. Measles virus is related to RSV, and both use the heparan sulfate proteoglycan (HSPG) for infection. NV-387 mimics HSPG, presents itself as a decoy to the virus, and is capable of destroying the virus particle thereby stalling the continuous infection and spread of virus in the body. This provides strong rationale for use of NV-387 to combat Measles virus.
Susceptible viruses CANNOT escape NV-387, even as they continue to evolve in the field into variants. Why? Because no matter how much the virus changes, it continues to use the same host-side signature to bind to and cause infection in the hosts, and thus the nanoviricide would be anticipated to continue to be effective even as the virus mutates to generate variants.
Thus NV-387 and other antiviral drugs designed on the nanoviricides platform can be expected to have decades of effective usability against the target viruses similar to the life of current antibiotics against bacterial infections but in stark contrast to current antiviral approaches.
A broad-spectrum antiviral drug such as NV-387 would be a highly desirable drug globally because it would enable treatment by physicians of patients as soon as they present symptoms of a viral disease without waiting for a test to identify a specific type of viral infection. This is reminiscent of how antibiotics are prescribed, without specific infectious agent identification, relying on the ultra-broad-spectrum of the drug.
NV-387’s Extremely Broad Antiviral is a Host Mimetic That Acts As a Decoy To Attract And Trap Many Diverse Viruses, Preventing the Virus from Replication and Reinfection of Other Cells
Over 90% of human pathogenic viruses are known to use one or more "landing sites" that are in the Sulfated Proteoglycans ("SPG") family. A successful host-mimetic nanoviricide drug using SPG as the key feature to attract viruses could theoretically be able to attack most if not all such viruses.
NV-387 is designed to mimic SPG and attack the virus as a cell-mimicking decoy. We have accumulated substantial evidence that in lethal viral infection animal studies, NV-387 demonstrated strong antiviral activity against a range of different virus families, exceeding or matching the activity of known approved drug agents.
Superior to Other Treatments
NV-387 was substantially superior to remdesivir in coronavirus infections, using a model for SARS-CoV-2 (COVID) virus, as reported earlier. We believe that NV-387 continues to be one of the most active antiviral drugs against multiple coronaviruses, and that it is a viable clinical candidate for drug development to treat COVID, Long COVID, as well as potentially MERS, SARS, and seasonal coronavirus infections.
In treating Influenza, NV-387 was substantially superior to the three approved drugs, namely Tamiflu®, Rapivab® , and Xofluza® against an Influenza H3N2 lethal lung viral infection study, as previously reported. We believe that NV-387 is expected to possess strong antiviral activity against H5N1 "Bird Flu" as well, given that H5N1 viruses are known to bind to heparan sulfate proteoglycans, and based on the observed broad-spectrum activity of NV-387.
NNVC has also found that NV-387 is capable of completely curing a lethal RSV lung virus infection in animals, leading to indefinite survival of the animals, as reported recently. There is no cure for RSV, and no approved drug for treatment of RSV infection other than the toxic last-resort drug ribavirin.
Moreover, even novel viruses, whether from natural sources or bio-engineered, are expected to be susceptible to NV-387 if they employ SPG for gaining access to human cells to infect and cause disease. Thus, NV-387 could be highly valuable for preparedness against novel viral epidemics and pandemics.
NV-387 could thus be a single drug to treat all of the "tripledemic" viruses (COVID, RSV, FLU ), and more, when so approved!
Finally, NV-387 was at least as effective as the approved drug tecovitrimat (TPOXX®, SIGA), in a lethal intra-digital infection by ectromelia virus in mice. Importantly, a combined drug made from NV-387 and tecovirimat was more effective than either drug alone, indicating NV-387 "plays well" with tecovirimat and acts by a different mechanism.
- Smallpox poses a significant biodefense threat. Ectromelia virus is a native virus of mice in the poxvirus family and is one of the key animal model viruses for developing smallpox therapeutics. Tecovirimat is an approved drug for treating smallpox infection based on the FDA "Animal Rule", and is stockpiled by the US "Strategic National Stockpile". It was mobilized during the recent monkeypox epidemic.
- It is important to develop additional smallpox therapeutics that work well with tecovirimat and by themselves, since viruses pose the threat of drug escape by mutation; further, in a bio-terrorism scenario, a human-engineered smallpox virus resistant to existing drugs could be a potential threat.
Host-Mimetic Technology Solves the Greatest Challenge for Antiviral Medicines, i.e. Virus Escape!
No matter how much a virus changes in the field, it uses the same "landing sites" in the host body to gain access to cells, attach to and then fuse into the cells, causing an infection. A drug using the same landing sites and acting as a "decoy" would remain effective against the virus even as the virus changes to form variants, because the host side does not change.
NV-387 is designed to employ such advanced "host-mimetic" technology, built into the nanoviricide™ nanomedicine that is further designed to "look like a cell" to the virus.
In contrast, vaccines, antibodies and small chemical drugs all lose their effectiveness as the virus changes in the field. The virus is constantly changing due to various natural mechanisms such as mutations, recombinations, and/or re-assortments that are native to the virus life cycle.
Given the broad spectrum of antiviral activity of NV-387 against viruses in many different virus families, NNVC believes that its effectiveness against Influenza A/H3N2 is indicative of potential antiviral activity against most if not all Influenza A viruses.
Ultra-Broad-Spectrum Antiviral Nanomedicines Enabled by the Nanoviricides Platform Would Open Up Very Large Market Opportunities For The Company
Even with a decline since 2022, COVID-19 continues to hospitalize and kill people in the USA – the CDC website states 69,200 hospitalizations and 2,652 deaths since January 1, 2024; the worldwide market size for COVID-19 therapeutics is expected to exceed $16.2 Billion in 2031*.
*Source: Transparency Market Research
The market size for RSV therapeutics was estimated to be $2 Billion in 2023 and is expected to rise to exceed $8.5 Billion by the year 2031**.
**Source: Growth+ Market Reports.
NANOVIRICIDES VARIANT-PROOF, SAFE TECHNOLOGY THAT DOESN’T NEED THE HOST IMMUNE SYSTEM WILL TRANSFORM THE WAY VIRUSES & THEIR VARIANTS ARE TREATED WORLDWIDE!
NNVC’s novel approach has already enabled variant-proof drugs, blocking the complete viral life cycle without requiring help from the host’s defense systems! If both the viral re-infection cycle, and viral replication cycle arms of the viral lifecycle are blocked, a cure for many viral diseases is possible!!
NV-387 Possesses Strong Anti-Influenza-A Virus Activity, and May Also Have Activity Against H5N1 Bird Flu Virus
NNVC reported that in a lethal animal model of lung infection by Influenza A /H3N2 virus, NV-387 was found to have substantially superior antiviral effects compared to three approved anti-influenza drugs.
The company performed a lethal lung infection study of mice infected with Influenza A/H3N2 that were treated with NV-387 or one of the three approved drugs for direct comparison: Oseltamivir (Tamiflu®, Roche), Peramivir (Rapivab®, Biocryst), and Baloxivir (Xofluza®, Shionogi, Roche).
In this study, NV-387 Oral treatment led to a survival lifespan of 15 days, compared to 10 days with Oseltamivir Oral treatment, 11 days with Peramivir I.V. treatment, and 11 days with Baloxivir Oral treatment, while the vehicle-treated and untreated (infected) animals survived only 8 days!
Thus the anti-Influenza activity of NV-387 given orally was substantially superior to all three of the approved anti-influenza drugs, namely Tamiflu, Rapivab, and Xofluza.
Given the broad spectrum of antiviral activity of NV-387 against viruses in many different virus families, NNVC believes that its effectiveness against Influenza A/H3N2 is indicative of potential antiviral activity against most if not all Influenza A viruses.
Nanoviricides, Inc. is close to having a single drug NV-387 for the treatment of all of the "tripledemic" respiratory viruses - Coronaviruses, RSV, and Influenza A, which would be a revolutionary achievement!
Learn More about Nanoviricides, Inc. by gaining access to the latest corporate presentation
Download Research ReportNANOVIRICIDES are better because they destroy viruses and their variants without relying on the patient's immune system, thereby making them effective for populations that include geriatric and pediatric patients.
- Antibodies only bind by two points to the virus, and destruction of the complex requires effective immune function, which is not the case in sick patients..
- Vaccines only train the body into producing antibodies against the virus in the vaccine. Antibodies and vaccines are easily overcome by viruses by mutating in the field, hence the need for annual influenza vaccine updates.
See Below for Nanoviricides' Unique, Novel, Post-Immunotherapeutic “Bind-Encapsulate-Destroy” Mechanism
THE BOTTOM LINE
With its ongoing expansion and development of their diverse and promising product pipeline, NanoViricides, Inc. (NYSE: NNVC) is positioned to be a dominant and innovative leader in the nanomedicine and antiviral therapy space.
NV-387 Could Revolutionize Antiviral Treatment Just as Antibiotics Did Against Bacteria!
The success of penicillin led to an explosion in development of antibacterials that use the same mechanism of action and provide additional benefits, stronger activity against certain bacteria and oral administration amongst them.
In fact, the world continues to use amoxicillin to treat most pediatric and adult bacterial infections to this day, some 65 years since its discovery in 1958! This durability is a direct result of the fact that most of the bacteria it attacks have not escaped the drug and have remained susceptible even after such a long time of common use.
NNVC has been able to develop NV-387 already for oral administration, as well as for injectable and inhalation formulations to enable many modes of use.
This comparison of features of nanoviricides technology platform and, in particular, NV-387, with the revolutionary antibiotics development against bacteria argues that NanoViricides (NYSE: NNVC) is now on a solid footing to revolutionize treatment of antiviral infections.
There is no denying that the world is changing… viruses are becoming more rampant. NNVC, an exciting NYSE company that is ahead of the problem, could see unstoppable growth ahead!
The company has sufficient funds to complete the on-going human clinical trials for its lead drug candidate NV-CoV-2 which is the drug product based on its "nanoviricide" active pharmaceutical ingredient ("API"), NV-387.
The successes of NV-387 as a broad-spectrum antiviral bode well for validating the multiple modalities in which NNVC’s Nanoviricides Platform Technology can be employed to revolutionize the treatment of viral infections as well as pandemic preparedness response.
This year the company has a focus on advancing NV-387 through phase II clinical trials of RSV, monkeypox/smallpox and other viruses including Flu/birdflu
NanoViricides, Inc.’s innovative platform technology, R&D agility, flexible cGMP compliant facility, highly effective management team, and extensive anti-viral experience should place this company at the top of your “invest” watchlist!
Learn More about Nanoviricides, Inc. by gaining access to the latest corporate presentation
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