Coronavirus Drug NV-CoV-2 IND Stage

SHELTON, CT / ACCESSWIRE / November 15, 2022 / NanoViricides, Inc. (NYSE American:NNVC) (the “Firm”), experiences that it has filed its Quarterly Report on Kind 10-Q for the fiscal first quarter ending September 30, 2022 with the Securities and Alternate Fee (SEC) on Monday, November 14, 2022. The report may be accessed on the SEC web site (https://www.sec.gov/Archives/edgar/data/1379006/000141057822003398/nnvc-20220930x10q.htm ).

We reported that, as of September 30, 2022, we had money and money equal present belongings steadiness of roughly $13.1 Million. As well as, we reported roughly $14.7 Million in Property and Tools (P&E) belongings (earlier than depreciation). The sturdy P&E belongings comprise our cGMP-capable manufacturing and R&D facility in Shelton, CT. The entire present liabilities had been roughly $0.51 Million. As compared, as of June 30, 2022, we had money and money equal steadiness of roughly $14.4 Million, P&E belongings of roughly $14.7 Million (earlier than depreciation), and complete present liabilities of roughly $0.41 Million. The web money utilized on this quarter was roughly $1.03 Million. The money expenditure is anticipated to extend as soon as scientific trials start for NV-CoV-2, our lead drug candidate to deal with SARS-CoV-2 an infection that causes COVID-19.

We estimate that we’ve got ample funds to finish preliminary human scientific trials for our lead drug candidate NV-CoV-2 for the remedy of SARS-CoV-2 an infection that causes the COVID-19 illness and in addition “lengthy COVID”.

Within the reported quarter, we imagine we’ve got considerably accomplished preparation of sure elements of an Investigational New Drug (IND) utility for submitting with the US FDA. We imagine that the remaining elements, involving scientific trial protocols and scientific trial group associated data, shall be accomplished after we interact a scientific trials analysis group (CRO) to conduct the trials. Thereafter we’ll assemble the IND package deal and file as acceptable. Beforehand, we’ve got compiled the doc known as “Investigator’s Brochure” pertaining to NV-CoV-2 that summarizes the developments and a possible scientific path for additional dialogue with a Scientific Analysis Group (CRO).

We’re diligently engaged on participating a Scientific Analysis Group (CRO) for finishing the proposed scientific trials data part of the IND, and for executing the human scientific trials.

We imagine that NV-CoV-2 addresses the unmet want for a protected and efficient remedy that can be utilized in in any other case wholesome sufferers in addition to in youngsters, primarily based on its sturdy security and effectiveness noticed in animal research. The at present out there antivirals have restricted applicability and effectiveness. Molnupiravir (Merck/Ridgeback) is severely restricted as a result of its mutagenicity and poor efficacy and unfavorable danger vs. profit profile. Paxlovid (Pfizer) was discovered to be not efficient in sufferers beneath 65 years of age and with out co-morbidities. Remdesivir requires infusion and is restricted to make use of in hospitalized sufferers with extreme illness.

NV-CoV-2 as oral syrup or oral gummies is anticipated to be helpful for sufferers in all age ranges and sufferers with or with out co-morbidities experiencing gentle to average COVID-19.
NV-CoV-2 Answer for Injection, Infusion, and Inhalation is designed to assist severely unwell hospitalized sufferers.

We imagine escape of latest variants of SARS-CoV-2 from our drug NV-CoV-2 is extremely unlikely. It’s because we developed NV-CoV-2 as a broad-spectrum, pan-coronavirus drug that’s energetic not solely in opposition to SARS-CoV-2, but additionally in opposition to different unrelated coronaviruses. We imagine that is precisely the sort of drug that’s wanted to fight the pandemic successfully and to have the ability to reside with the virus, as a worldwide society, because the SARS-CoV-2 virus is transferring in direction of an endemic part.

We imagine that NV-CoV-2 works by a novel mechanism of motion; that of blocking the re-infection cycle of the viral illness. We imagine that NV-CoV-2 not solely binds to the virus, however fuses with the virus floor, uprooting the glycoproteins which are required for the virus to bind to the human cell (S protein, and its merchandise S1 and S2 proteins), thereby rendering the virus incapable of infecting a cell. In distinction, antibodies are solely able to adorning the virus, usually incompletely.

Beforehand, the Firm has accomplished preclinical improvement of its lead drug candidate for the remedy of shingles rash, particularly, NV-HHV-1. The Firm intends to re-engage this program with submitting an IND and performing scientific trials for NV-HHV-1 regulatory approvals after our COVID-19 program.

The nanoviricide platform know-how is a number one nanomedicine know-how that uniquely allows assault on each (a) the virus particles outdoors cells and (b) the replication of virus inside cells. If each of those elements may be managed successfully, then the ensuing drug might be a treatment for the viral illness. In distinction, antibodies solely bind to the virus particles outdoors cells, and tag them for the immune system for additional processing, whereas antiviral small chemical medicine have an effect on solely the replication cycle of the virus inside cells.

Moreover, in response to current occasions, we initiated a restricted program for improvement of nanoviricide drug candidates in opposition to an infection by Monkeypox virus (and associated different poxviruses). We additionally initiated a restricted program for improvement of nanoviricide drug candidates in opposition to an infection by Enterovirus D68 (EVD68), and probably broad-spectrum medicine in opposition to enteroviruses together with poliovirus (PV). EVD68 is linked to a pediatric illness known as acute flaccid myelitis (AFM) that may result in paralysis (AFP). Just lately, PV has been discovered circulating within the USA, significantly in New York, ensuing from a revertant of an attenuated PV viral pressure that’s used as a polio vaccine in sure nations. PV is taken into account an essential public well being risk in gentle of decreased charges of childhood polio vaccinations within the USA and another developed nations.

Our anti-viral therapeutics, that we discuss with as “nanoviricides®” are designed to imitate and look to the virus just like the native host cell floor to which it binds. We imagine that our drug candidates can be troublesome for a virus to flee as a result of these binding websites for a given virus don’t change regardless of mutations and different adjustments within the virus. Additional, we imagine that our medicine shall be broad-spectrum, i.e. efficient in opposition to most if not all strains, varieties, or subtypes, of a given virus, offered the virus- binding portion of the nanoviricide is engineered appropriately.

The nanoviricide platform is designed to moreover maintain small molecule energetic pharmaceutical elements (API’s) of various varieties in its “stomach”. This enables focused supply of the encapsulated API to contaminated cells, and can be anticipated to enhance the pharmacokinetic and pharmacodynamic properties of the API, reminiscent of fast metabolism. Fast metabolism is thought to be an effectiveness-limiting issue for a lot of medicine, together with remdesivir. Remdesivir, developed by Gilead, is a drug that interferes with the replication of the SARS-Cov-2 virus and has been accepted beneath emergency use rules within the USA in addition to in lots of different nations.

About NanoViricides

NanoViricides, Inc. (the “Firm”) (www.nanoviricides.com) is a improvement stage firm that’s creating particular goal nanomaterials for antiviral remedy. The Firm’s novel nanoviricide® class of drug candidates are designed to particularly assault enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 for the remedy of COVID-19 illness brought on by SARS-CoV-2 coronavirus. Our different superior candidate is NV-HHV-1 for the remedy of Shingles (beforehand known as NV-HHV-101). The Firm can’t challenge an actual date for submitting an IND for any of its medicine due to dependence on plenty of exterior collaborators and consultants. The Firm is at present targeted on advancing NV-Cov-2 into Section ½ human scientific trials.

NV-CoV-2 is our nanoviricide drug candidate for COVID-19 that doesn’t encapsulate remdesivir. NV-CoV-2-R is our different drug candidate for COVID-19 that’s made up of NV-CoV-2 with remdesivir encapsulated inside its polymeric micelles. The Firm believes that since remdesivir is already US FDA accepted, our drug candidate encapsulating remdesivir is more likely to be an approvable drug, if security is comparable. Remdesivir is developed by Gilead. The Firm has developed each of its personal drug candidates NV-CoV-2 and NV-CoV-2-R independently.

The Firm can be growing medicine in opposition to plenty of viral illnesses together with oral and genital Herpes, viral illnesses of the attention together with EKC and herpes keratitis, H1N1 swine flu, H5N1 chicken flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, amongst others. NanoViricides’ platform know-how and applications are primarily based on the TheraCour® nanomedicine know-how of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide unique perpetual license to this know-how for a number of medicine with particular focusing on mechanisms in perpetuity for the remedy of the next human viral illnesses: 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 Chook Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and sure Coronaviruses. The Firm intends to acquire a license for poxviruses and/or enteroviruses if the preliminary analysis is profitable. The Firm’s know-how relies on broad, unique, sub-licensable, area licenses to medicine developed in these areas from TheraCour Pharma, Inc. The Firm’s enterprise mannequin relies on licensing know-how from TheraCour Pharma Inc. for particular utility verticals of particular viruses, as established at its basis in 2005.

As is customary, the Firm should state the chance issue that the trail to typical drug improvement of any pharmaceutical product is extraordinarily prolonged and requires substantial capital. As with all drug improvement efforts by any firm, there may be no assurance presently that any of the Firm’s pharmaceutical candidates would present ample effectiveness and security for human scientific improvement. Additional, there may be no assurance presently that profitable outcomes in opposition to coronavirus in our lab will result in profitable scientific trials or a profitable pharmaceutical product.

This press launch incorporates forward-looking statements that replicate the Firm’s present expectation concerning future occasions. Precise occasions might differ materially and considerably from these projected herein and depend upon plenty of elements. Sure statements on this launch, and different written or oral statements made by NanoViricides, Inc. are “forward-looking statements” throughout the that means of Part 27A of the Securities Act of 1933 and Part 21E of the Securities Alternate Act of 1934. You shouldn’t place undue reliance on forward-looking statements since they contain identified and unknown dangers, uncertainties and different elements that are, in some instances, past the Firm’s management and which might, and certain will, materially have an effect on precise outcomes, ranges of exercise, efficiency or achievements. The Firm assumes no obligation to publicly replace or revise these forward-looking statements for any cause, or to replace the explanations precise outcomes might differ materially from these anticipated in these forward-looking statements, even when new data turns into out there sooner or later. Vital elements that might trigger precise outcomes to vary materially from the corporate’s expectations embody, however usually are not restricted to, these elements which are disclosed beneath the heading “Danger Components” and elsewhere in paperwork filed by the corporate every now and then with the USA Securities and Alternate Fee and different regulatory authorities. Though it isn’t attainable to foretell or determine all such elements, they might embody the next: demonstration and proof of precept in preclinical trials {that a} nanoviricide is protected and efficient; profitable improvement of our product candidates; our capability to hunt and procure regulatory approvals, together with with respect to the indications we’re searching for; the profitable commercialization of our product candidates; and market acceptance of our merchandise.

FDA refers to US Meals and Drug Administration. IND utility refers to “Investigational New Drug” utility. cGMP refers to present Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers back to the Committee for Medicinal Merchandise for Human Use, which is the European Medicines Company’s (EMA) committee accountable for human medicines.

CONTACT:

NanoViricides, Inc.
[email protected]

Public Relations Contact:
MJ Clyburn
TraDigital IR
[email protected]

SOURCE: NanoViricides, Inc.

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