NanoViricides Initiates New Drug Development To Combat Monkeypox Virus

NanoViricides, Inc. NNVC reports that it has begun drug development to combat the monkeypox virus.

Specifically, the company has initiated a program to screen its library of broad-spectrum antiviral nanoviricides against certain poxviruses in order to develop broad-spectrum poxvirus therapeutics that act by mechanisms other than tecovirimat 

The company is about to complete the synthesis of most of the compounds it intends to screen from its library of compounds that have shown broad-spectrum effectiveness against certain viruses.

The impending human clinical trials of the company's lead SARS-CoV-2 drug candidate, NV-CoV-2, are anticipated to enable a rapid timeline to success in the company's Monkeypox Initiative.

Additionally, the company expects that it may be possible to encapsulate tecovirimat (the active component of TPOXX®, SIGA) within the NV-387 nanomicelles, to improve its safety and PK/PD over the current delivery mode which is complexation with a cyclodextrin component that is known to lead to adverse reactions in renally impaired (i.e. kidney damage) patients.

NV-387 was shown to be safe in multiple animal studies and its safety is due to be evaluated in human clinical trials for which the company has mostly completed the documents needed for an application. The company has been working on initiating these clinical trials in multiple countries. The company has also demonstrated the ability of NV-387 to encapsulate and improve the pharmacokinetics and pharmacodynamics of a very difficult drug, namely remdesivir, that is formulated in a cyclodextrin-based formulation at present (Veklury® Gilead).

The company's top priority remains initiating human clinical trials of its SARS-CoV-2 drug candidate NV-CoV-2 to combat COVID-19. The company believes it is very close to filing a clinical trial application for COVID-19, although the timelines are outside of the company's control.

The company intends to develop both systemic treatments (injectable and oral treatments) to control monkeypox virus infection, as well as possibly a skin cream for topical treatment of the monkeypox rash, if successful. The company has developed systemic injectable and oral formulations of its drug candidate NV-CoV-2 for treating SARS-CoV-2 variants that are continuing to extend the COVID-19 pandemic. Previously the company has developed a broad-spectrum antiviral skin cream to topically treat the Shingles rash. Monkeypox is unrelated to the chickenpox virus that causes Shingles although both are DNA viruses. The company has no expectation that the shingles drug candidate may be effective against monkeypox rash.

The company believes it can successfully develop a drug candidate against poxviruses in a relatively short period of time, if one or more of its existing pipeline candidates or other nanoviricide candidates in its drug candidate library are found to be effective. To this end, the company has developed an antiviral assay for testing these drug candidates against infection by certain poxviruses in cell cultures in its own BSL2 Virology facility. If cell culture studies are successful, the company intends to progress its active drug candidates into animal model studies for the purpose of identifying a clinical candidate, and then rapidly progress to additional IND-enabling studies.

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 candidate NV-CoV-2, as well as for the production of necessary amounts of doses for a potential monkeypox virus therapeutic, and the anticipated clinical trials of NV-HHV-101 skin cream for the treatment of shingles.

The company is in the process of completing a clinical trial application for its COVID-19 drug candidate, NV-CoV-2, and the filing is expected to occur soon. Additionally, the company has 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.

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