SHELTON, CT / ACCESSWIRE / April 25, 2022 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform is providing an update on its clinical-trial ready Coronavirus Oral and Injectable Drug Programs.
NanoViricides is close to completing an Investigators Medicinal Product Dossier that is required as part of the clinical trial application for its lead drug candidate for the treatment of COVID-19, NV-CoV-2. Simultaneously the Company is rapidly getting its manufacturing systems set up for producing the drug products for the clinical trials.
The Company believes it has sufficient funds for the Phase I/II human clinical trials of this COVID-19 drug candidate.
The NV-CoV-2 drug candidate is designed to act by a novel mechanism of action, that the Company calls "Re-infection Blocker". NV-CoV-2 has been found to have pan-coronavirus activity, which suggests that it should continue to work against emerging variants of SARS-CoV-2, the pandemic coronavirus.
It will be possible to combine NV-CoV-2 with other treatments for improved effect, if necessary, because the mechanism of action of NV-CoV-2 is orthogonal to the mechanisms of most if not all other known COVID-19 drugs.
As new variants of SARS-CoV-2 have evolved over time, their transmissibility has increased. The new Omicron BA.2 variant and its descendants (such as XE) are almost as contagious as the measles virus, one of the most contagious viruses known, according to scientists (https://news.yahoo.com/omicron-variants-explained-everything-know-220059889.html).
Scientists have repeatedly warned that a more severe variant that retains this high transmissibility and escapes available vaccines and antibodies could emerge anywhere, given the wide spread of the global pandemic. At present, a fourth booster shot is only expected to protect against new infection for about eight weeks, although protection against severe disease is likely much longer lasting, according to an Israeli study (https://www.nejm.org/doi/pdf/10.1056/NEJMoa2201570?articleTools=true).
A further danger lurking out there is that, a new variant could emerge in vaccinated persons that actually uses the vaccine-induced antibodies to hitch a ride on them and cause more severe infections, known as "Antibody-Dependent Enhanced" (ADE) Effect. SARS-CoV-1 and MERS-CoV are known to be capable of generating ADE mutants, and thus this possibility cannot be ignored for their close cousin, SARS-CoV-2, the current pandemic virus, according to scientists (https://www.statnews.com/2022/02/16/coronaviruses-are-clever- evolutionary-scenarios-for-the-future-of-sars-cov-2/).
Thus, we need to be prepared with an effective broad-spectrum, pan-coronavirus drug. Such a drug would continue to work against the emerging virus variants.
The Company believes NV-CoV-2 is exactly the drug that the world needs today, based on pre-clinical studies. Further, NV-CoV-2, based on its strong safety profile, is not expected to have any restrictions on its use such as those that have dogged currently available oral therapies, namely Paxlovid (Pfizer) and Molnupiravir (Merck).
NV-CoV-2 was found to be a broad-spectrum, pan-coronavirus drug candidate in pre-clinical studies. Escape of virus due to variants is expected to be highly unlikely because of this broad-spectrum antiviral activity of NV-CoV-2. NV-CoV-2 was also found to be significantly more effective than remdesivir in animal studies of lethal direct lung coronavirus infection that simulates the SARS-CoV-2 disease. Remdesivir is the only fully approved drug for the treatment of SARS-CoV-2 (COVID-19) at present, and is highly effective in cell culture studies, but has limited effectiveness in clinical studies.
Moreover, the mechanism of action of NV-CoV-2 is orthogonal to that of Paxlovid™ (Pfizer). Thus the two therapies can be given together for synergistic effect.
NV-CoV-2 has been found to be extremely safe and non-mutagenic in GLP and Non-GLP Safety/Toxicology studies. NV-CoV-2 has demonstrated good oral bioavailability in animal studies. The Company believes that an effective oral drug to treat COVID-19 remains an unmet medical need.
The Company has developed "Oral Gummies" formulation of NV-CoV-2 successfully. Oral gummies are expected to be more acceptable to children and older patients because of slow dissolution in the mouth and palatability than oral pills that may be difficult to swallow.
The Company has completed formulation and stability studies for the oral and injectable dosage forms of NV-CoV-2.
The Company is currently conducting manufacturing scale-up of the formulated materials into drug products. The manufacturing scale-up for the active ingredient, called NV-387, is now completed as required for initiating human clinical trials.
The NV-CoV-2 Oral Gummies will be made available in blister packs. The Company has devised a novel production method for this novel presentation of an oral antiviral drug. The Company has successfully designed the blister packs and the equipment for making the blister packs. The Company has devised custom equipment for filling and sealing the blister packs based on our novel production method.
The NV-CoV-2 Oral Syrup will be made available in sealed plastic bottles for the clinical trial supply. The Company intends to move to single-use dose-packets of the oral syrup once the dosage can be finalized based on clinical trials.
Bench scale equipment for production of the NV-CoV-2 Blister Packs as well as NV-CoV-2 Oral Syrup that is sufficient for the Phase I human clinical trials is being commissioned already. This equipment will be used to speed up the entry into Phase I/IIa clinical trials. Automated, larger scale custom equipment is on order. The automated equipment is expected to be set up in working condition for Phase II human clinical trials.
The Company has also developed NV-CoV-2 formulations for injection, infusion and direct lung inhalation using a simple mouthpiece. The inhalation drug formulation is expected to benefit severely ill patients as it enables delivering much higher levels of drug (than infusion or oral dosing) directly to the lung tissue thereby helping to minimize the lung viral load and lung damage, for rapid recovery of hospitalized patients.
NanoViricides is one of a few biopharma companies that has its own cGMP-compliant manufacturing facility. The Company intends to produce its drugs for clinical trials in this facility. The Company has the capability to produce sufficient drugs for about 1,000-5,000 patients in a single batch of production, depending upon the drug and the dosage. This production capacity is anticipated to be sufficient for the Phase I and Phase II human clinical trials for our anti-coronavirus drug in development, as well as for the anticipated clinical trials of NV-HHV-101 skin cream for the treatment of shingles.
The Company has previously completed IND-enabling studies for another drug candidate, NV-HHV-101 for the treatment of shingles rash caused by reactivation of the chickenpox virus (aka varicella-zoster virus, VZV). The Company plans on further developing the shingles drug candidate into human clinical trials after clinical trials of our COVID-19 drug candidate. The Company has additional drugs in its pipeline at various pre-clinical stages that it plans to develop towards regulatory approvals after the COVID-19 and Shingles drug 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. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, we are developing a clinical candidate for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. 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 now working on tasks for completing an IND application. 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 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 has executed a Memorandum of Understanding with TheraCour that provides a limited license for research and development for drugs against human coronaviruses. The Company intends to obtain a full license and has begun the process for the same. 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.
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.
