NanoViricides, Inc. (NYSE American: NNVC)’s lead drug candidate is NV-387 (drug product NV-CoV-2) for the treatment of RSV, COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections.
Susceptible viruses CANNOT escape NV-387, even as they continue to evolve in the field, enabling NNVC to anticipate that nanoviricide drugs could have many decades long of “life of service.”
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.
Thus NV-387 and other antiviral drugs designed on the nanoviricides platform can be expected to have a long duration of effective usability against the target viruses, reaching into several decades, similar to antibiotics, but in stark contrast with current antiviral approaches.
An antiviral drug such as NV-387 if found to be effective in human clinical studies would be a highly desirable drug globally. It would enable treatment of patient as soon as they present to the physician with a viral disease without waiting for a test for identifying which viral infection it is.
This is reminiscent of how antibiotics are prescribed, without specific infectious agent identification, relying on the ultra-broad-spectrum of antibacterial activity.
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.
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.
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.
NV-387 was at least as good as TPOXX® in a model animal study for the development of Smallpox/Mpox drugs, in two different ways of acquiring infection, as reported earlier.
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, and more, when so approved!
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, 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 lifecycle.
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.
Previously, on November 14, 2023, we have reported that in a lethal intradigital footpad infection of mice with ectromelia virus, oral NV-387 treatment led to lifespan improvement comparable to oral tecovirimat treatment, with both treatments resulting in 14 days survival, whereas vehicle treated animals died in 8 days. Moreover, combined treatment with both NV-387 and tecovirimat resulted in a significantly improved survival of 17 days in this study.
Tecovirimat is the drug approved for smallpox under "animal rule" and is stockpiled by the Biomedical Advanced Research and Development Authority (BARDA). It was mobilized from the stockpile during the recent MPox Clade 2 pandemic.
BARDA is interested in development of additional poxvirus therapeutics as per a recent Broad-Agency Announcement (BAA). There is significant interest in the development of a smallpox therapeutic 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.
NNVC believes that NV-387 is a viable clinical candidate to be developed by itself for the treatment of poxvirus infections under the US FDA "Animal Rule". In addition, the company believes that the combination of NV-387 and tecovirimat could reduce the potential for escape resistant generation against tecovirimat, as is known with other drug combination studies against viruses.
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!
As biotech stages a big comeback, NanoViricides, Inc. (NYSE American: NNVC) looks well-positioned to be a market disruptor with nontoxic, effective antiviral therapies based on patented nanomedicine technology.
NanoViricides, Inc. (NYSE American: NNVC) is a global leader in the application of nanomedicine technologies to the safe and effective treatment of viruses and their variants INCLUDING drugs against Covid-19, RSV and other respiratory viruses!
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.
Analysts have said that the 2023 year-end spurt of biopharma mergers and acquisitions bodes well for the sector this year. The SPDR S&P Biotech ETF, which tracks the sector, had a strong November and December.
The recent AbbVie-ImmunoGen deal “may be the start of more consistent activity we will see in 2024,” RBC Capital Markets analyst Brian Abrahams wrote in a note published late recently. “We do believe we are likely past the XBI bottom and can look to somewhat improved enthusiasm for the group—in part driven by M&A—into 2024.”
AbbVie spent about $18.8 billion on two large deals in a matter of seven days.
According to an RBC Capital, the cumulative value of biopharma deals in 2023 has been $128 billion, up from $61 billion in 2022. Major acquisitions announced include Pfizer’s $43 billion deal for the cancer-focused biotech Seagen, and Merck’s $10.8 billion deal for the immunology-focused biotech Prometheus Biosciences.
ANTIBODIES AND VACCINES ARE OUTDATED: NanoViricides, Inc. has a more innovative approach that works even when viruses mutate!!!
NV 387 IN CLINICAL TRIALS
The drug, developed in response to the COVID-19 pandemic, demonstrated exceptional safety in clinical trials, even at the highest dose levels, with NO adverse events reported. The unique mechanism of action involves mimicking a cell membrane, encapsulating and blocking the virus.
Beyond COVID-19, the drug also displayed promising results against respiratory syncytial virus (RSV), offering a potential solution for infants and seniors where existing treatments like ribavirin may be contraindicated due to side effects.
The clinical trials involved both oral tablets and oral gummies, catering to various age groups, including pediatrics. NV 387 exhibited broad-spectrum activity against multiple strains of coronaviruses, showcasing effectiveness 10 times greater than remdesivir in preclinical studies.
The ongoing clinical trial progress and positive results position NanoViricides at the forefront of antiviral drug development, marking a significant milestone in their journey from preclinical research since 2005 to clinical trials.
The company believes 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 from coronaviruses), thereby rendering the virus incapable of infecting a cell. In contrast, antibodies are only capable of covering the virus, generally incompletely, and require immune system assistance for clearing the resulting complex!
NNVC developed NV-387 in response to the COVID pandemic as a broad-spectrum, pan-coronavirus antiviral. It is designed to "look like a cell" to the virus, displaying copious amounts of sites to which the virus binds on the surface of the nanoviricide nanomicelle, to trap and destroy the virus particle, rendering the virus incapable of infecting another cell.
The company calls this novel antiviral mechanism "Re-Infection Blocker".
In particular, NV-387 was designed to emulate an "attachment receptor family" called sulfated proteoglycans (S-PG), that over 90% of human pathogenic viruses are known to use for infecting cells. Therefore, in addition to Coronaviruses, RSV and Smallpox, the company anticipates that NV-387 may have effectiveness against many other viruses.
NNVC plans on continuing to study the antiviral spectrum of NV-387 with a view to expand its applications.
NV-387 could usher in a new era in the treatment of antiviral infections, if it is found to be broadly effective against additional viruses that use S-PG, evoking a comparison to how antibiotics changed the treatment of bacterial infections.
There is a significant unmet medical need for a broad-spectrum antiviral drug that is effective and useable in all segments of the population. There are substantial limitations for all currently approved COVID drugs in terms of both the eligibility of a COVID patient, and the effectiveness of the drug.
NNVC believes that the excellent safety and the distinctly different mechanism of NV-CoV-2 (NV-387) support the use of this drug across all patient populations. This is an important characteristic for a COVID drug as well as for a drug to treat RSV infection.
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.
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!!
The Company’s virus-specific nanoviricides have been created against important viruses such as HIV, Influenza and Bird Flu by choosing highly virus-specific ligands.
Broad-spectrum nanoviricides have been created that can bind to possibly as many as 90-95% of known viruses. The Company is also developing broad-spectrum nanoviricides to combat several neglected tropical diseases, such as Dengue, Rabies, and Ebola/Marburg.
With its ongoing expansion and development of their diverse and promising product pipeline, NanoViricides, Inc. is positioned to be a dominant and innovative leader in the nanomedicine and antiviral therapy space.
Led by the inventor of nanoviricides technology President, Dr. Anil Diwan, and managed by a highly effective team with decades of entrepreneurial, pharmaceutical, and nanomedicine experience, Nanoviricides, Inc. has been able to keep both administrative and R&D costs at extremely low levels while expanding the drug pipeline.
Creator and developer of nanomedicine technologies, Dr. Anil R. Diwan co-founded NanoViricides and currently serves as the company’s President and Executive Chairman. Diwan has over 35+ years of experience in entrepreneurship and bio-pharmaceutical R&D, including the invention of novel polymeric micelle-based nanomedicine technologies in 1991, the birth of NanoViricides, Inc in 2005, the uplisting from OTC to NYSE-mkt in 2013, and now the first clinical trials of its COVID-19 drug in 2023. Along the way, Dr. Diwan has led several of the finance efforts and has raised over 60+ MM in equity financing and has over 60 patents issued internationally resulting from three fundamental international patent applications.
Before that, he has won several NIH SBIR (Small business innovation research) grant awards and holds a Ph.D. from Rice University, TX, a B.Tech. from Indian Institute of Technology, Mumbai (IIT-B), India where he held high scholastic ranks.
NV-387 Could Revolutionize Antiviral Treatment Just as Antibiotics Did Against Bacteria!
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!
As biotech stages a big comeback, one NYSE-traded company looks well-positioned to be a market disruptor with nontoxic, effective antiviral therapies based on patented nanomedicine technology.
This global leader in broad-spectrum antiviral nanomedicines had remarkable news recently, revealing that the antiviral activity of its NV-387 oral treatment against RSV/A2 is strong enough to have resulted in full survival of lethally infected animals. The company believes the NV-387 oral treatment is capable of curing RSV infection. Why is this important? Because there is currently no approved treatment for RSV other than ribavirin. A safe and effective treatment remains an unmet medical need!
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 further clinical trials, expanding its treatment capabilities to address unmet medical needs. This includes RSV, the flu, and other viruses.
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!
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