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The Sustained, Slow Declining, Blood Concentration Profile of NV-387 Enables Infrequent Dosing for Strong Antiviral Effect

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NanoViricides announced a significant advancement in its lead antiviral agent, NV-387. This drug, designed for broad-spectrum antiviral treatment, has shown prolonged blood concentration levels in non-human primate models, indicating the potential for infrequent dosing. NV-387's unique polymeric design helps sustain drug levels, making it effective for moderate to severe viral infections like RSV, COVID, and influenza. The drug demonstrated superior performance over existing antiviral drugs in preclinical studies and is expected to proceed to Phase II clinical trials for RSV.

Positive
  • NV-387 showed a sustained blood concentration profile, indicating potential for infrequent dosing.
  • The drug was more effective than existing treatments like Tamiflu and Remdesivir in preclinical models.
  • NV-387 has broad-spectrum antiviral activity, making it useful against multiple viral infections including RSV, COVID-19, and influenza.
  • Successfully completed Phase 1a/1b human clinical trials with no reported adverse events.
  • Injectable formulation of NV-387 is developed, suitable for moderate to severe illnesses.
Negative
  • No assurance that preclinical success will translate to clinical efficacy.
  • The drug development process is lengthy and requires significant capital investment.
  • Dependence on external collaborators may result in delays for IND filings and subsequent trials.
  • Current Phase II trials are to RSV, with no specific timeline for trials on other viruses.

The sustained, slow declining blood concentration profile of NV-387 observed in the non-human primate model suggests a significant advancement in antiviral therapy. The ability to maintain therapeutic levels of the drug for an extended period allows for less frequent dosing, which can improve patient compliance and reduce healthcare costs. This pharmacokinetic profile is especially relevant in treating chronic viral infections like COVID-19 and Long COVID, where continuous antiviral activity can be beneficial.

The potential broad-spectrum efficacy of NV-387 against various viruses, including RSV, Influenza and coronaviruses, underscores its versatility. Comparing its effectiveness to existing treatments like Tamiflu, Rapivab, Xofluza and remdesivir, NV-387 shows promise in offering superior antiviral activity. This broad application could simplify treatment regimens, reducing the need for multiple antiviral drugs.

From a clinical perspective, the injectable and inhalation formulations offer flexibility in treating different severities of infections. The ability to deliver the drug directly to the lungs through nebulization is particularly advantageous in severe respiratory infections, providing targeted therapy where it is most needed.

The promising data from NanoViricides' NV-387 could have substantial implications for the Company's financial health. The reduced frequency of dosing and broad-spectrum activity can position NV-387 as a preferred option in the antiviral market, potentially capturing significant market share from established drugs. However, it is essential to consider the risks associated with drug development, including the lengthy approval process and the substantial capital required.

The successful completion of Phase 1a/1b trials without adverse events is a positive indicator, but the transition to Phase II and further clinical trials will be critical. Investors should monitor these developments closely, as any setbacks could impact the Company's valuation. Additionally, the Company's licensing agreements and dependence on external collaborators could pose risks if these partnerships face challenges.

In terms of market potential, if NV-387 proves to be effective in Phase II and subsequent trials, it could become a significant revenue driver for NanoViricides, especially given its potential applications across multiple viral infections. This diversification reduces the risk associated with dependency on a single drug or a narrow therapeutic area.

The introduction of an antiviral agent like NV-387 with a broad-spectrum activity can disrupt the current antiviral market. The ability to treat a wide range of viral infections with a single drug could simplify treatment protocols and appeal to healthcare providers and payers. The comparison with existing drugs like Tamiflu, Rapivab, Xofluza and remdesivir suggests that NV-387 might offer a compelling alternative both in terms of efficacy and potential cost-effectiveness.

The potential market for NV-387 extends beyond immediate treatment of viral infections to encompass long-term conditions like Long COVID. This expansion into chronic conditions could create a substantial and sustained revenue stream. The current limitations of drugs like Paxlovid highlight an unmet need in the market, which NV-387 aims to fill.

Investors should also consider the competitive landscape and regulatory environment. The broad-spectrum nature of NV-387 positions it well against competitors, but the Company will need to navigate complex regulatory pathways, especially given the diverse viral targets. Success in this space could solidify NanoViricides' position as a leader in antiviral nanomedicine.

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

SHELTON, CT / ACCESSWIRE / June 4, 2024 / NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company"), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, reports on the highly desirable blood concentration profile of its lead clinical stage broad-spectrum antiviral agent NV-387 upon intravenous (I.V.) administration in a non-human primate (NHP) animal model.

The Company has found that its lead nanoviricide broad-spectrum antiviral drug candidate NV-387, when given as a slow bolus intravenous infusion, resulted in a relatively flat plateau of blood concentration of the drug with very slow decline over a 24 hour period in a cynomolgus monkey model.

The maximum concentration as well as the plateau concentration increased in a dose-dependent manner, as expected.

This sustained drug level in the blood stream for a relatively long period of time enables infrequent dosing. It is the result of the unique polymeric design of NV-387. NV-387 is a "chemical nanomachine". It is made up of polymer with its size chosen to minimize loss by renal filtration.

The observed pharmacokinetic profile of NV-387 supports a once-daily or less frequent dosing regimen.

The Company has already developed an injectable formulation of NV-387, namely NV-387 Solution for Injection, Infusion, and Inhalation.

An injection of NV-387 would be useful for moderate to severe illness, especially because of the sustained blood profile that requires infrequent dosing.

An infusion would be suitable for severely ill hospitalized patients.

Importantly, this NV-387 Solution can be readily delivered directly into the lungs of a patient using a simple handheld nebulizer over a period of a few minutes. Such delivery can enable direct attack on the virus where such attack is most needed in the cases of severe lung infection.

The utility of NV-387 is extremely broad, reminiscent of the utility of antibiotics.

We have found that NV-387 could cure lethal lung infection in RSV infected animals even with an oral dose. There is no approved drug for RSV treatment other than the toxic, last resort drug ribavirin, which was not very effective in this lethal study compared to NV-387.

We have also found that NV-387 IV administration as well as PO (Oral) administration was substantially superior to each of the approved drugs Tamiflu, Rapivab and Xofluza in an Influenza A/H3N2 lethal lung infection model.

We believe that NV-387 is expected to possess similar strong antiviral activity against Influenza A/H5N1 "Bird Flu" viruses as well. Our belief is based on the putative mechanism of NV-387. NV-387 is a host-mimetic, direct acting antiviral designed as decoy, to look like a cell decorated with sulfated proteoglycans, to which over 90% of human pathogenic viruses including H5N1 are known to bind.

We have found that NV-387 has strong antiviral activity against all tested coronaviruses, including SARS-CoV-2 pseudovirions. NV-387 was substantially more effective than remdesivir in a lethal coronavirus infection animal study. We believe that NV-387 has a strong potential for the treatment of COVID as well as "Long COVID".

COVID continues to cause substantially more fatalities annually than Influenza viruses. Long COVID has substantial personal as well as societal costs. Available drug, Paxlovid (Pfizer) has significant limitations for patient suitability. Thus a new drug against COVID and Long COVID is sorely needed.

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 NanoViricides' lead antiviral agent?

NanoViricides' lead antiviral agent is NV-387.

How does NV-387 work?

NV-387 is a host-mimetic, direct-acting antiviral designed to mimic cell features to which viruses bind, thereby dismantling them.

What viral infections does NV-387 target?

NV-387 targets RSV, COVID-19, influenza, and other respiratory viral infections.

What is the significance of NV-387's blood concentration profile?

NV-387's sustained blood concentration profile allows for infrequent dosing, improving treatment adherence and effectiveness.

How did NV-387 perform in preclinical studies?

NV-387 showed superior performance compared to existing antiviral drugs like Tamiflu and Remdesivir in preclinical studies.

What is the status of NV-387's clinical trials?

NV-387 has completed Phase 1a/1b human clinical trials with no adverse events and is advancing to Phase II trials for RSV.

NanoViricides, Inc.

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