Shelton, Connecticut — (November 15, 2021) – NanoViricides, Inc. (NYSE American: NNVC) (the “Company”), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, announced today that it has developed oral gummies formulations of its Pan-Coronavirus COVID-19 Drug Candidate NV-CoV-2 to benefit non-hospitalized patients. Additionally, the Company has developed formulations for direct inhalation into lungs to benefit severely ill hospitalized patients. The Company also reports strong safety of NV-CoV-2 on several parameters in animal models.
NV-CoV-2 has been found to be an Extremely Safe and Non-mutagenic Drug, as described below:
The Company reports that NV-CoV-2 has been found to be non-immunogenic and non-allergenic. Further, it has not caused any hypersensitivity or adverse reactions at injection site or other adverse events in multiple animal studies. It was safe and well tolerated at very high dosages in single and multiple-dosing studies below the maximum tolerable dose (MTD) in animal models, based on available data. The maximum tolerable dosage in rats was determined to be 1,500 mg/Kg.
The Company also reports that NV-CoV-2 has been found to be non-mutagenic in a standard GLP Ames Test.
The Company believes that the extremely strong safety observed in animal models should be indicative of a strong safety signal anticipated in Phase 1 human clinical trials.
The non-immunogenicity, non-allergenicity, and lack of hypersensitivity or adverse reactions at injection site seen in animal models with single and repeated injections leads the Company to postulate that it may be possible to give a therapeutic dose of NV-CoV-2 in humans via a simple slow-push injection rather than an infusion. If this proves out in clinical trials, it would enable treating moderate cases without hospitalizing the patients. This is an important unmet need that would help significantly reduce the severe and intense load on hospitals and health-care workers that occurs during the waves of the global COVID-19 pandemic.
NV-CoV-2 and NV-CoV-2-R Drug Formulations for Oral, Injectable, Infusion, and Direct Lung Inhalation:
NanoViricides has developed formulations of both NV-CoV-2 and NV-CoV-2-R to meet the needs of different levels of disease severity and different types of patients.
The Company has recently completed the development of an oral gummies (“chewable gel”) formulation of NV-CoV-2. The Company believes that this formulation may have advantages in terms of drug bioavailability over oral pills, because of partial sublingual absorption that avoids the gastrointestinal tract. NanoViricides maintains that this oral gummies formulation would be very attractive to patients, especially children, over oral pills. This formulation would be for the benefit of symptomatic non-hospitalized patients, Additionally, the simplicity of administration is expected to enable its prophylactic use as well.
The Company has previously developed an injectable formulation of NV-CoV-2 that it believes may not require infusion, allowing treatment of severe cases without hospitalization. This is an important unmet need for reducing strain on hospital systems during waves of the global COVID-19 pandemic.
Previously, the Company has developed formulations for infusion for both NV-CoV-2 and NV-CoV-2-R, to treat severely ill hospitalized patients.
NanoViricides has also very recently developed formulations of both NV-CoV-2 and NV-CoV-2-R for direct inhalation into lungs using a simple nebulizer. This inhalation formulation is developed to benefit very severely ill patients with significant lung pathology. Direct inhalation of the drug would result in highest possible levels of the drug to be achieved in lungs thereby maximizing antiviral effect, and minimizing lung viral load. This is expected to help minimize lung damage, enabling the patient to recover rapidly.
The Company has previously demonstrated that NV-CoV-2 was highly effective in multiple cell culture studies against unrelated coronaviruses including SARS-CoV-2 (S-protein pseudovirion), h-CoV-NL63 (NL63), and h-CoV-229E (229E). 229E causes common colds. NL63 causes a COVID-19-like lung pathology in humans, but the disease is not very severe. SARS-CoV-2 has caused the current global pandemic that continues with multiple waves driven by evolution of new variants. Thus the Company has established the broad-spectrum pan-coronavirus activity of NV-CoV-2.
As new variants emerge, the effectiveness of vaccines has continued to drop, the protection from the antibodies developed in response to the vaccine has continued to decrease, and antibody drugs have become progressively less effective. Thus a broad-spectrum pan-coronavirus drug is needed to help end the pandemic. NanoViricides has recognized this need right at the onset and believes it has successfully developed drug candidates that precisely satisfy this as-yet unmet need.
NanoViricides asserts that there is a much lower probability of generation of escape mutants against NV-CoV-2 (as compared to the classical types of drugs) (1) because it is designed to create a multi-point attack on the virus thereby completely disrupting the virus structure, and (2) because of the observed broad-spectrum activity of NV-CoV-2 against multiple types of distinctly different coronaviruses including SARS-CoV-2.
“We believe that NV-CoV-2 and NV-CoV-2-R would be highly effective drugs against SARS-CoV-2, based on multiple animal studies data,” commented Dr. Anil Diwan, Chairman and President of the Company, adding, “We believe that NV-CoV-2 may help end the pandemic if it is shown to be effective in human clinical trials.”
NanoViricides, Inc. (the “Company”) (http://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. We are developing clinical candidates for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, the Company has several antiviral programs in various pre-clinical stages.
The Company is now working on tasks for completing an IND application for its COVID-19 drug candidates. The Company cannot project an exact date for filing an IND for this drug because of its dependence on a number of external collaborators and consultants. The Company is currently pursuing two separate drug candidates for the treatment of COVID-19 patients. NV-CoV-2 is our nanoviricide drug candidate that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2 with remdesivir encapsulated in it. 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 intends to re-engage into an IND application to the US FDA for NV-HHV-101 drug candidate for the treatment of shingles once its COVID-19 project moves into clinical trials, based on resources availability. The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization for COVID-19 drug development work.
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 Coronavirus infections, 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 and Ebola/Marburg viruses. 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 that 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.
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.
Source: NanoViricides, Inc.