SHELTON, CT / ACCESSWIRE / July 1, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, elaborates on its current assets and plans towards becoming a successful pharmaceutical company intending to revolutionize the treatment of viral infections.
NV-387, our lead broad-spectrum antiviral drug candidate has completed Phase I clinical trial in healthy subjects with no drop-outs and no reported adverse events, indicative of excellent safety and tolerability in humans.
This single drug, NV-387, has been found to be highly active against a number of different types of viruses. In fact, its activity has, in animal models:
Resulted in curing lethal lung RSV infection;
Substantially bested the activities of approved drugs (Tamiflu, Xofluza, Rapivab) for Influenza;
Substantially bested the activity of Remdesivir against lethal coronavirus infection; and
Matched the activity of TPOXX against poxvirus.
We believe that this ultra-broad-spectrum antiviral activity of NV-387 became possible because NV-387 is designed to mimic an invariant host feature that over 90% human pathogenic viruses employ for attachment and infection.
A single antiviral drug that can effectively treat almost any respiratory viral infection would be a revolutionary development in the treatment of viral diseases, reminiscent of the revolution caused by penicillin in the treatment of bacterial infections, we believe.
We are rapidly moving towards Phase II studies to establish effectiveness against a viral disease in humans. We plan on Phase II studies for RSV, with the goal of developing a therapeutic for the treatment of pediatric patients, which is the greatest unmet need in RSV infection.
The market sizes for the viral diseases that NV-387 has already been found to be a viable clinical drug candidate as above are substantial.
The market size for RSV is estimated at $2.6 Billion in 2024, growing to $4.3 Billion in three years, at a rate of 18.9% as reported by GrowthPlusReports1.
The market size for Influenza and Bird Flu is estimated at $4.6 Billion in 2024, growing to an estimated $5.9 Billion in three years, at a rate of 8.5% as reported by DelveInSight2. In case a pandemic occurs, reality may outrun such projections by magnitudes, as was seen with the COVID pandemic.
The market size for COVID, as it has become an endemic disease by now, can be expected to be similar to the market size for Influenza while new COVID drugs are being developed, since COVID continues to cause at least twice as large a fatality rate as Influenza in the USA alone.
Thus we estimate an overall market size of around $16 Billion in three years for these three viruses, that NV-387 is expected to tackle.
Thus NV-387 alone is poised to propel NanoViricides towards great success in a near-term horizon. We plan to license or co-develop our various drug candidates against multiple viral diseases to other Pharma Companies. In addition, we plan on seeking non-dilutive funding for the development of drugs that are of interest for biodefense.
We have already demonstrated the ability to manufacture our own drug candidates at several Kilograms scales in cGMP-compliant processes for clinical trials. Our campus comprises a multi-Kg scale cGMP-compliant manufacturing facility with Class 100 clean rooms. We have demonstrated capabilities for manufacture of the drug substance, and thereafter formulate, fill-finish-and-package the drug products for clinical trials in this facility.
We believe that our existing manufacturing facility would be adequate for market entry of NV-387 for the pediatric patients segment when the drug is approved by the FDA.
We also have a drug in development against herpesviruses, NV-HHV-1, formulated as a skin cream, that we plan on advancing through clinical trials for regulatory approval as a topical treatment of Shingles/Chickenpox skin rashes, HSV-1 "cold sores", as well as HSV-2 "genital ulcers". NV-HHV-1 had completed IND-enabling studies by October 2019 just before the COVID-19 pandemic broke out, whereupon we took up the challenge of developing a highly effective drug to treat all coronavirus infections. We have an oral formulation of NV-HHV-1 in development for systemic use to treat herpesvirus infections.
Our unique, host-mimetic, directly virus-attacking, technology platform has enabled the development of a number of drug candidates against several viral diseases. We believe these developments will continue to provide additional drug candidates to feed our pipeline for several years to come.
Thus, we believe that we are on the verge of substantial success and expansive growth in the near future:
having successfully completed Phase I of our first drug candidate,
having amassed substantial data demonstrating superior antiviral activity of our drug candidates in animal models,
and now being poised to enter into Phase II human clinical trials.
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.
References:
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