"NanoViricides Broad Spectrum Technology Represents Potential Paradigm Shift In Viral Therapy"; "Novel Anti-Viral Could Boost a US$3 Billion Market" - Conclude Two Independent Research Reports on NanoViricides

Rhea-AI Summary

NanoViricides, a clinical-stage leader in antiviral nanomedicines, has gained significant attention through two independent research reports. The reports emphasize the broad-spectrum potential of NanoViricides' lead drug candidate, NV-387, which has shown efficacy in preclinical trials against multiple viruses, including RSV, Influenza A, and COVID-19. This compound could disrupt the $3 billion market for antiviral therapies. The company's transition into clinical-stage development and upcoming Phase 1 and 2 trials are key milestones. Analysts highlight the promise of NV-387 as an orally deliverable antiviral medication that could be widely prescribed, marking a potential breakthrough in treating viral respiratory infections.

Positive

• NV-387 shows broad-spectrum efficacy in preclinical trials against RSV, Influenza A, and COVID-19.
• Potential to disrupt the $3 billion antiviral market.
• Upcoming Phase 1 and Phase 2 clinical trials for NV-387.

Negative

• No assurance that preclinical successes will translate into clinical success or marketable products.

Insights

Biotechnology Analyst

NanoViricides' broad-spectrum antiviral technology, particularly NV-387, shows promising potential in treating multiple respiratory viruses. The preclinical data demonstrating efficacy against influenza, RSV and potentially COVID-19 is particularly noteworthy. If successful, this could indeed represent a paradigm shift in antiviral therapy.

Key points to consider:

• The potential for a single drug to target multiple viruses could significantly streamline treatment protocols and reduce healthcare costs.
• The oral delivery method of NV-387, if proven effective, would greatly enhance its market potential and accessibility.
• The $3 billion RSV market mentioned provides a substantial opportunity, but competition from existing vaccines and antibodies should be factored in.
• While preclinical results are promising, it's important to await Phase 1 clinical trial results to better assess NV-387's safety and efficacy in humans.

Investors should closely monitor the progress of NV-387's clinical trials and any updates on its efficacy against different viral strains. The broad-spectrum approach, if validated in humans, could position NanoViricides as a significant player in the antiviral market.

Financial Analyst

From a financial perspective, NanoViricides' potential entry into the $3 billion RSV market with a broad-spectrum antiviral represents a significant opportunity. However, several factors warrant consideration:

• Market penetration: As a new entrant, NanoViricides will face competition from established players. The company's ability to capture market share will depend on NV-387's efficacy, safety profile and pricing strategy.
• Clinical development costs: Advancing NV-387 through Phase 2 trials and potentially into multiple indications will require substantial capital. Investors should scrutinize the company's cash position and funding strategy.
• Regulatory pathway: The broad-spectrum nature of NV-387 may complicate the regulatory approval process. The FDA's approach to approving a multi-indication antiviral could impact timelines and costs.
• Partnerships: Given the potential market size, NanoViricides might benefit from partnering with larger pharmaceutical companies for late-stage development and commercialization.

While the potential is significant, investors should remain cautious given the early stage of development and the inherent risks in biotechnology investments. The company's ability to successfully navigate clinical trials and regulatory hurdles will be important in realizing the projected market opportunity.

Medical Research Analyst

The potential of NanoViricides' NV-387 as a broad-spectrum antiviral agent is intriguing from a medical research perspective. Several aspects deserve attention:

• Mechanism of action: The company's nanoviricide technology, designed to attack and dismantle enveloped virus particles, represents an innovative approach. This mechanism could potentially address issues of viral resistance seen with traditional antivirals.
• Broad-spectrum efficacy: Preclinical data showing effectiveness against multiple respiratory viruses (influenza, RSV, potentially COVID-19) is promising. However, it's important to see how this translates to human trials, as the complexity of the human immune system can often yield different results.
• Comparative efficacy: The report mentions "excellent preclinical data on Influenza A treatment with NV-387 compared to existing blockbuster therapies." Quantitative data comparing NV-387 to current standards of care will be essential in upcoming clinical trials.
• Long COVID potential: If NV-387 shows efficacy against Long COVID, it could address a significant unmet medical need, as current treatments are

While the preclinical data is encouraging, it's important to maintain a measured outlook. Many promising preclinical candidates fail to show the same efficacy in human trials. The upcoming Phase 1 results will be important in validating the safety and potential efficacy of NV-387 in humans.

SHELTON, CT / ACCESSWIRE / August 1, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage global leader in broad-spectrum antiviral nanomedicines, reports that two separate and independent research reports have been published by industry analysts on the Company.

"NNVC: NanoViricides Broad Spectrum Technology Represents Potential Paradigm Shift In Viral Therapy," is the title of a new research note published by David Bautz, PhD, Zacks SCR, on July 31st, 2024. Importantly, he notes that, "As opposed to currently available antiviral therapies in which each compound is only active against a unique type of virus, NanoViricides has disclosed preclinical results for NV-387 in multiple viral models that demonstrates the broad-spectrum action of the compound. These results could represent a new paradigm in viral therapy."

"NanoViricides is now a clinical stage company with an exciting, potentially broad-spectrum antiviral asset in NV-387. The preclinical results showing efficacy in different viral models is supportive of the drug's potential utility as a therapeutic against a wide range of viruses. We look forward to the final results from the Phase 1 clinical trial of NV-387 as well as the company's expected timeline for moving it into a Phase 2 trial in RSV and additional indications that will be pursued," concludes Dr. Bautz.

"[NanoViricides'] Novel anti-viral could boost a US$3 bln market - New focus on viral respiratory infections especially highly transmissible RSV," is the title of the research report published by John Savin, PhD, MBA, ProactiveInvestors, focusing on our clinical stage drug NV-387, on May 21st, 2024, in a separate and independent Research Report.

"If, as preclinical data indicates, the candidate, anti-viral NV-387, can be delivered orally at effective doses against multiple respiratory viruses, including potentially Influenza A, RSV and COVID-19, it could become a mass market product. It might be prescribed by primary care physicians adding a new, acute therapeutic category to the RSV vaccine and antibody market already worth about US$3 billion," proclaimed Dr. Savin.

"As preclinical work shows that NV-387 is effective against influenza and RSV viruses, a general anti-viral first response oral therapy against "Severe Acute Respiratory Infection"-Viral (SARI-Viral) might be feasible," noted Dr. Savin, adding, "We also note excellent preclinical data on Influenza A treatment with NV-387 compared to existing blockbuster therapies."

The ZacksSCR research note can be found at https://scr.zacks.com/news/news-details/2024/NNVC-NanoViricides-Broad-Spectrum-Technology-Represents-Potential-Paradigm-Shift-in-Viral-Therapy-/default.aspx . It is available on Yahoo Finance at https://finance.yahoo.com/news/nnvc-nanoviricides-broad-spectrum-technology-100900860.html . The report is also available on NanoViricides' website.

The detailed ProactiveInvestors Research Report can be found under https://www.proactiveinvestors.com/companies/news/1048095/novel-anti-viral-could-boost-a-us-3-bln-market-1048095.html . The report is also available on NanoViricides' website.

NanoViricides provided publicly available information to each Analyst at the time he began preparing the report. In addition, the Analysts had external access as well as access via our own website to any further public information reported in our press releases, SEC filings, and public presentations. The Analysts performed their own research. The research reports or notes and opinions expressed therein are the Analysts' own opinions and work products, and NanoViricides did not have any say in the content or opinions in the reports, while the Analysts' Companies were compensated for the reporting activity by NanoViricides. ProactiveInvestors notes that they do not offer investment advice. Zacks notes that "Because of individual financial or investment objectives and/or financial circumstances, this report or article should not be construed as advice designed to meet the particular investment needs of any investor."

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. Our lead drug candidate is NV-387 for the treatment of RSV, COVID-19, Long COVID, Influenza, and other respiratory viral infections. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles (previously referred to as NV-HHV-101). 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 currently focused on advancing NV-387 into Phase II human clinical trials.

NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.

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.

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".

CONTACT:
NanoViricides, Inc.
info@nanoviricides.com

Public Relations Contact:
ir@nanoviricides.com

SOURCE: NanoViricides, Inc.

View the original press release on accesswire.com

FAQ

What is NanoViricides' drug candidate NV-387?

NV-387 is NanoViricides' lead antiviral drug candidate, showing broad-spectrum efficacy in preclinical trials against viruses like RSV, Influenza A, and COVID-19.

What is the market potential for NV-387?

NV-387 could become a mass-market product, potentially disrupting the $3 billion market for antiviral therapies.

When are the clinical trials for NV-387 expected?

NanoViricides is progressing NV-387 into Phase 1 clinical trials and plans to move into Phase 2 trials targeting RSV and other indications.

What did the independent research reports say about NV-387?

The reports highlighted NV-387's broad-spectrum action in preclinical models and its potential to be an orally deliverable antiviral medication, marking a new paradigm in viral therapy.