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A First-In-Class, Broad-Spectrum Antiviral Agent Intending To Revolutionize Treatment of Viral Infections Including RSV, COVID, Influenzas and More

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NanoViricides, a leader in broad-spectrum antiviral nanomedicines, has developed NV-387, a first-in-class antiviral agent targeting RSV, COVID-19, Influenza, and other viruses. NV-387 employs novel host-mimetic technology to remain effective despite viral mutations. It has outperformed existing drugs such as remdesivir, Tamiflu, and TPOXX in preclinical studies. NV-387 has successfully completed Phase I human trials with no reported adverse events, demonstrating strong safety profiles. The drug is now poised for Phase II trials. NanoViricides holds exclusive perpetual licenses for several antiviral treatments and collaborates with Karveer Meditech in India.

Positive
  • NV-387 demonstrated superior effectiveness over remdesivir, Tamiflu, and TPOXX in preclinical studies.
  • NV-387 has shown broad-spectrum activity against multiple viruses, including RSV, COVID-19, and Influenza.
  • Completed Phase I human trials with no adverse events reported.
  • Strong safety profile indicated through high NOAEL and MTD values.
  • Potential to treat novel viral epidemics and pandemics due to broad effectiveness.
  • Holds exclusive licenses for various antiviral therapies, enhancing market potential.
Negative
  • No assurance that preclinical success will translate to clinical success or market approval.
  • Significant capital required for continued development and clinical trials.
  • Dependence on external collaborators and consultants could delay progress.
  • Risk factor of lengthy drug development timelines inherent in pharmaceutical industry.

The development of NV-387 by NanoViricides, Inc. introduces a potentially groundbreaking antiviral agent with broad-spectrum efficacy. The agent's ability to mimic host cells and act as a decoy to viruses is innovative. This approach could reduce the problem of virus resistance, a significant issue with current antiviral therapies.

While the Phase I clinical trial results are promising, with no adverse effects reported, it's critical to recognize that Phase I trials primarily assess safety rather than efficacy. The assertion that NV-387 was superior to existing drugs like remdesivir and others in preclinical models is noteworthy, but these results need validation in human Phase II and III trials to confirm efficacy and safety in broader populations.

If NV-387 proves effective in further trials, it could potentially change the landscape of antiviral treatments. However, it’s important for investors to temper expectations until more extensive clinical data is available. The versatility in dealing with various viruses could make it a valuable asset in addressing both current and future viral threats.

NanoViricides' announcement about NV-387's development is potentially significant for its market valuation. The company's stock might see positive movement due to the promising preliminary results and the broad antiviral spectrum of NV-387. However, caution is advised as the drug is still in the early phases of development.

Clinical trials are costly and time-consuming and there is a risk of failure at any stage. Investors should consider the company's ability to secure funding for ongoing and future trials. The promised versatility and effectiveness of NV-387, if proven, could lead to substantial market opportunities. However, due diligence is essential, focusing on the company's financial health and its strategy for navigating the remaining clinical phases.

The potential of NV-387 in addressing multiple viral infections positions NanoViricides in a unique space within the pharmaceutical market. If successful, NV-387 could appeal across multiple markets, including influenza, COVID-19 and other respiratory viruses. Given the ongoing need for versatile antiviral treatments, the drug could meet a significant unmet demand.

Market penetration will depend on regulatory approvals and the outcome of comprehensive clinical trials. The compound’s performance against a wide array of viruses provides a compelling market proposition, potentially reducing the need for multiple antiviral drugs. This could make NV-387 an attractive option for healthcare providers and policy makers, particularly in pandemic preparedness.

However, market adoption will also depend on the cost of production, pricing strategy and the competitive landscape. Investors should keep an eye on these factors as the drug progresses through development stages.

Novel Host-Mimetic, Virus Killing Technology Platform

SHELTON, CT / ACCESSWIRE / May 29, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, elaborates on its development of a first-in-class, broad-spectrum antiviral agent that could revolutionize treatment of viral infections including RSV, COVID, Influenzas and other viruses.

"Resistance is Futile" - Host-Mimetic Technology To Solve the Greatest Pain 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, 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.

Extremely Broad Antiviral Spectrum of NV-387 Resulted Because Many Diverse Viruses Use Common Host-Side Landing Sites

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.

Further, we 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.

Safety of NV-387 Studied Successfully in Phase I Human Clinical Trials with No Adverse Events

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 our studies.

Leading to the human clinical trials, we 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. We 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. We are awaiting reports from the CRO to further elaborate on the findings.

"An antiviral agent with an extra-ordinarily broad spectrum of antiviral activity, coupled with strong safety, is a ‘holy grail' of antiviral medicines," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, adding, "Our host-mimetic, direct-acting, nanoviricide™ platform technology capable of destroying virus particles has made this possible, we believe. NV-387 is now ready for Phase II studies towards the goal of regulatory approvals worldwide." He further commented, "If and when approved, NV-387 could be as revolutionary an antiviral agent as penicillin was as an anti-bacterial agent."

About NanoViricides

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. Additionally, nanoviricides mimick the host-side features that the viruses continue to require in spite of mutations, and therefore the viruses would be highly unlikely to escape the nanvoricide drugs.

Our 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. NV-387 has successfully completed a Phase 1a/1b human clinical trial in healthy subjects with no reported adverse events even at the highest and repeated dosages. This trial was conducted by the drug sponsor, Karveer Meditech Pvt. Ltd., our licensee and collaborator in India.

The Company is currently focused on advancing NV-387 into Phase II human clinical trials for treatment of RSV infection.

Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 "cold sores" and HSV-2 "genital ulcers". The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants.

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, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for poxviruses and/or enteroviruses if the initial research is successful. 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.

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 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.

The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

"NOAEL" means "No-Observed-Adevrese-Event-Level", which is the maximum dosage employed at which there were no adverse events found in animal studies.

"MTD" means "Maximum Tolerated Dose", which is the maximum dosage employed that does not compromise survival of the animals.

FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". API means active pharmaceutical ingredient.

Contact:

NanoViricides, Inc.
info@nanoviricides.com

Public Relations Contact:
MJ Clyburn, TraDigital IR
clyburn@tradigitalir.com

SOURCE: NanoViricides, Inc.



View the original press release on accesswire.com

FAQ

What is NV-387 and what viruses does it target?

NV-387 is a broad-spectrum antiviral agent targeting RSV, COVID-19, Influenza, and other viruses.

How does NV-387's host-mimetic technology work?

NV-387 uses host-mimetic technology to remain effective against viruses despite mutations, acting as a decoy to attract and neutralize the virus.

What were the results of NV-387's Phase I clinical trials?

NV-387 Phase I clinical trials were completed successfully with no reported adverse events.

How does NV-387 compare to existing antiviral drugs?

NV-387 has been shown to outperform existing antiviral drugs like remdesivir, Tamiflu, and TPOXX in preclinical studies.

What is the next step for NV-387?

The next step for NV-387 is advancing to Phase II human clinical trials.

NanoViricides, Inc.

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