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.
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.
The nanoviricide technology involves copying the invariant and essential host-side signature and, using this signature, building a direct-acting antiviral that destroys the virus. This design feature of nanoviricides solves the most intractable issue in antiviral response, that of viruses escaping the vaccines, antibodies, and small chemical drugs.
NV-387 is designed using the host-side signature that over 90% of human pathogenic viruses use for creating a successful infection in the human or animal hosts. This means NV-387 is likely to be active against a large number of viruses and could be sufficiently active against many of them to become a successful clinical drug against them.
In fact, the company has already demonstrated that NV-387 is highly effective in preclinical studies against lethal RSV infection as well as against lethal Smallpox-like virus infections!
NV-387 has completed a Phase 1a/1b human clinical trial in healthy subjects with no reported adverse events even at the highest and repeated dosages.
The Company is currently focused on advancing NV-387 into Phase II human clinical trials for the treatment of RSV infection.
NNVC has reported that the antiviral activity of NV-387 against RSV/A2 is strong enough to have resulted in the full survival of lethally infected animals!
In this study, extended dosing of NV-387 given orally was compared with a high dose of ribavirin given orally for the same duration. Two doses were given on first day of dosing followed by one daily dose for next 9 days (for a total of 11 doses). NV-387 given by this dosing regimen led to complete survival of the mice beyond the 21 days study period, with no signs of pathology (disease) apparent on the last day of observation. In contrast, ribavirin led to death of all animals by 14 days!
Ribavirin is the only currently approved drug for RSV infection, that can be used only as a last resort because of its extensive toxicity that limits its effectiveness.
Lethally RSV Infected Animals Orally Treated with NV-387 Showed Normal Lung Histology, Indicating Potential Cure!
NanoViricides, Inc. (NYSE American: NNVC) recently revealed that the strong antiviral activity of NV-387 against RSV/A2 is clearly demonstrated by lungs remaining normal and showing no infection-related damage, when treated orally with NV-387, in a lethal lung RSV infection animal model. The animals in only the NV-387 treated group survived completely, as previously reported.
In contrast, lethally infected animals in the Ribavirin oral treatment group showed progressive lung pathology, demonstrating progressive inflammation in the lung tissue which resulted in moderate levels of inflammation as well as infected cells in the inflammatory infiltrate on day 10, increasing to severely infected lungs with alveolitis and severe pneumonia by day 13. All animals in the ribavirin-treated RSV infected group died by 14 days.
The complete survival and clear lungs indicate that NV-387 treatment completely protected the animals and could be potentially a cure for RSV infection!
RSV is an important disease in infants and children less than 5 years old, as well as in older persons over 65 years old. According to the CDC, each year in the United States, RSV leads to approximately:
Two vaccines have recently been approved for protection of persons 60+ years old from RSV infection (Arexvy®, GSK, and Abrysvo®, Pfizer).
Abrysvo was recently approved for use in pregnant women for protection of infants. Synagis (palivizumab), an antibody, as well as a new antibody, nirsevimab (Beyfortus®) have been approved by the US FDA for protection of newborn children at risk of RSV disease.
No approved treatment currently exists for RSV other than ribavirin. This means a safe and effective treatment remains an unmet medical need and offers NNVC an incredible market opportunity.
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.
COVID is here to stay, and even as the pandemic has largely subsided, the need for COVID therapeutics is in the range of tens of billions of dollars.
Long COVID also remains a problem that effective antiviral such as NV-387 could make a difference in. An estimated 17 million adults currently have long COVID.
NNVC’s Phase I Clinical Trial of NV-387 is completed successfully and data lock is expected soon!
The Phase 1 clinical trial, protocol number KM-NVCoV2-001, which received approval from the regulatory agency in India for healthy as well as COVID-19 participants, was closed and completed in April by the Drug Sponsor and the company’s licensee, Karveer Meditech, Pvt. Ltd., and the CRO, PristynCR, in India.
The decision to close the clinical trial with healthy subjects study completed was taken because diligent efforts to identify suitable COVID-19 participants for the clinical trials were met with a notable absence of positive cases at the designated clinical trial sites, despite addition of a second site during January/February 2024.
Both the single ascending dose part of this clinical trial (called Phase 1a), and the subsequent multiple ascending dose part (called Phase 1b) have been completed with healthy subjects. There were no reported adverse effects, indicating excellent safety of both of the drug products, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies, at all of the dosage levels given to the subjects. The CRO is now in the process of completing database input of all of the subjects’ clinical datasets to achieve datalock for further statistical analysis.
As previously reported, NV-387, the active ingredient in the drug products in this clinical trial, has been demonstrated to possess an extremely broad effectiveness against multiple virus families in lethal animal studies evaluating NV-387
NNVC has also demonstrated that NV-387 is highly effective in preclinical studies against lethal RSV infection as well as against lethal Smallpox-like virus infections.
NanoViricides reports that in a lethal animal model of lung infection by Ectromelia virus, oral dosing with NV-387 led to an increase in lifespan of mice that was comparable to oral treatment with tecovirimat (TPOXX®, SIGA), the approved drug against Smallpox.
Read more at: https://www.miamiherald.com/press-releases/article288412389.html#storylink=cpy
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.
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!
NV-387 is inherently designed to be safe, by careful choice of the components of the nanoviricide polymeric chemical, and this was borne out in the company’s studies.
Leading to the human clinical trials, NNVC had found that the safety of NV-387 was demonstrated by the very large NOAEL value of 1,200mg/Kg and MTD value of 1,500mg/Kg in rats. NNVC had also found that NV-387 was non-mutagenic, non-genotoxic, non-immunogenic, and studies indicated that allergenicity was not an issue; all parameters that indicate excellent safety.
A Phase I clinical trial of NV-387 Oral Syrup and NV-387 Oral Gummies was completed successfully with no adverse events reported. The company is awaiting reports from the CRO to further elaborate on the findings.
The company has recently reported that its clinical stage lead nanoviricide broad-spectrum antiviral drug candidate, NV-387, results in an ideal flat blood concentration profile for an extended time period upon oral administration in two different animal models!
This unusual but highly desirable, extended flat time profile of blood concentration of orally given NV-387 enables sustained antiviral effect over a long period of time, allowing infrequent dosing regimens.
The blood concentration profile of NV-387 is indicative of the formation of a buffering reservoir of the drug in the host that releases the drug at a regular rate into the bloodstream.
The flat time profile of NV-387 indicates that even at very high doses, its blood concentration is unlikely to result in unwanted side effects!
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.
Discover how NV-387 acts by a novel mechanism here: https://www.nanoviricides.com/technology.html
The strong safety and tolerability of NV-387 demonstrated in human clinical trial implies that it can be used:
Dr. Diwan has been President and Chairman of the Board of the Company since its founding in 2005 Dr. Diwan spearheaded the efforts for the Company’s 2013 uplisting from the OTC Markets to NYSE-American. Dr. Diwan has led several of the Company’s financing efforts since 2010.
Dr. Diwan invented novel polymeric micelle-based nanomedicine technologies as early as 1991. Dr. Diwan is a prolific inventor and a serial entrepreneur. Prior to co-founding NanoViricides, Inc., he has founded TheraCour Pharma, Inc., a privately held company focused in nanomedicines and cell-targeted drug delivery, and AllExcel, Inc., a company with diverse portfolios including nanomedicines, small chemicals, device technologies, as well as informatics. He has won several NIH SBIR (small business innovation research) grant awards. Anil holds a Ph.D. from Rice University, TX, a B.Tech. from Indian Institute of Technology, Mumbai (IIT-B), India, and has consistently held high scholastic ranks and honors. Dr. Diwan has over 25 years of Bio-Pharmaceutical R&D experience with over 20 years as an entrepreneur.
He has several patents issued internationally resulting from three fundamental international patent applications. Under Dr. Diwan’s leadership, NanoViricides, Inc. has been able to keep both administrative and R&D costs at extremely low levels while robustly expanding the drug pipeline every year. Dr. Anil R. Diwan was recognized as “Researcher of the Year” by BusinessNewHaven, a Connecticut Area Business Journal, in 2014.
Ms. Vyas is known as a strong leader with board level experience and successful achievements as a Senior Executive in a broad range of entities including publicly listed corporations, non-revenue generating entities, and medium to large size companies. Meeta has over twenty-five years of experience in performance and process improvement of both publicly listed companies and non-revenue producing entities, in areas ranging from Finance and Operations to Strategy and Management. Meeta holds the distinction of being the first Indian woman to be named CEO of a publicly listed US corporation, Signature Brands, Inc., best known for “Mr. Coffee” and “Health-O-Meter” brand products. As CEO, acting COO and Vice Chairman of the Board of Signature Brands, Inc., she was responsible for the development and implementation of a turnaround plan, resulting in a return to profitability and growth within a short period of time. Later, as the CEO of the World-Wide Fund for Nature – India (WWF-India) and then as a Vice President of the National Audubon Society (USA), both non-revenue generating entities, Meeta successfully raised unrestricted funding that significantly exceeded annual requirements and also instituted financial processes to measure a variety of performance metrics. Earlier in her career, she was responsible for designing the strategy and initiating the implementation plan for the highly successful information technology outsourcing program at General Electric (GE). Also at GE, Ms. Vyas ran GE Appliances’ Range Products business unit having revenues exceeding $1 Billion where her team doubled operating income in less than two years. Prior to that, as a management consultant with McKinsey and Company, she served publicly listed companies in chemicals, industrial, and technology markets, primarily focusing on growth strategies, valuations, post-merger integrations, and logistics operations. Meeta is married to NanoViricides, Inc. President and Chairman Anil R. Diwan.
Ms. Vyas holds a MBA in Finance from Columbia University’s Graduate School of Business, and a BS in Chemical Engineering from the Massachusetts Institute of Technology.
NanoViricides won the IAIR AWARD as Best North American Company for Leadership in the Nanomedicine Sector.
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.
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.
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