Star Metro - WHO Extended Global Emergency Status of MPox Epidemic - Development of Treatment for MPox with NV-387 is Timely, Says NanoViricides

The Director General of WHO has extended the PHEIC declaration for MPox epidemic according to a WHO news release dated July 10, 2025, following continuing upsurge of the MPox virus (MPXV) epidemics in the African region^[1].

Sporadic travel related cases of MPXV Clade I have occurred outside Africa, including in the USA, but so far have not resulted in further transmission. The threat of such sustained transmission continues, and is part of the decision to continue the PHEIC status.

"Our development of NV-387 towards Phase II clinical trial for treatment of MPOX is timely for responding to the continuing threat of a global spread of MPox, and for meeting the need for treatment of MPox patients in Africa, in light of the continuing spread of MPox," said Anil R. Diwan, PhD, President and Executive Chairman of NanoViricides, Inc., adding, "If successful, this NV-387 clinical trial will also open up a multi-billion-dollar global market of preparedness for poxvirus bioterrorism to us."

At present, there is no drug approved, that is actually safe and effective in humans, for the treatment of the MPox disease, which is caused by MPXV infection. Tecovirimat (SIGA) has failed to show any effectiveness over standard of care in a clinical trial for treatment of MPXV infections. Brincidofovir treatment resulted in drug-induced liver disease in three out of three treated MPox patients resulting in cessation of therapy, and did not show any effectiveness in these patients according to a peer reviewed "retrospective observational study" also called "non-randomized study"^[2], ^[3]. In spite of this, a clinical trial of brincidofovir for treating MPox was initiated under an international coalition led by US CDC and first patient was dosed around January 2025 in this "MOSA" clinical trial^[4]. The topline results from this clinical trial regarding safety and efficacy were anticipated by CY Q2 (i.e. June, 2025). We have not found any press releases announcing any such results.

The orthopoxviruses can escape both small chemical drugs, tecovirimat and brincidofovir, by mutations, according to peer reviewed scientific articles^[5].

The above factors clearly highlight the need for an effective therapeutic for the treatment of MPOX.

In contrast to the small chemical drugs, vaccines, antibodies, that viruses escape readily, NV-387, the novel broad-spectrum antiviral developed by the Company, is designed such that viruses would not escape the drug. This is because NV-387 mimics the cell-side feature called heparan sulfate proteoglycans (HSPG) to which the viruses bind and concentrate next to the cell before they can attack the cell and cause infection. No matter how much a human pathogenic virus mutates, it continues to bind to HSPG. Over 90% of human pathogenic viruses are known to bind to HSPG.

Additionally, NV-387 has been found to be extremely safe and well tolerated in a Phase I human clinical trial. There were no reported adverse events or serious adverse events in this clinical trial. In animal studies, NV-387 was found to be extremely safe, with a No-Observed-Adverse-Event Level (NOAEL) of the drug at 1,200 mg/kg, and the Maximum Tolerated Dose (MTD) at 1,500 mg/kg in intravenous injection in rats. The Phase I clinical trial results for NV-387 were consistent with the safety observations in animal model studies.

NV-387 is orally available and is formulated as oral gummies that are soft solids that do not require swallowing, and are designed to dissolve in the oral cavity itself. This is important because MPox patients may not have the ability to swallow pills or capsules because of viral lesions in the oral cavity.

The Company recently announced that it has completed the development of a clinical trial protocol for the impending Phase II study of NV-387 for the treatment of MPox disease in the African Region. This will be a randomized clinical trial comparing NV-387 treatment with the Standard of Care, to evaluate the dosing regimen for NV-387, the safety and tolerability of the dosing regimen in MPox patients, and effectiveness of NV-387 on the MPXV virus and the MPox disease that it causes.

Of note, both tecovirimat and brincidofovir were approved by the US FDA for smallpox virus, based on the "Animal Rule", which avoids the use of human efficacy clinical trials that would be unethical to conduct with a smallpox challenge study in humans.

We also note that smallpox is a more severe disease than even the most severe form of MPox disease, and both of these drugs have been found to be inadequate for the treatment of MPox according to currently available datasets (although definitive data from the brincidofovir clinical trial has not been released yet).

These two drugs (tecovirimat and brincidofovir) have been acquired in the US Strategic National Stockpile for bioterrorism preparedness to the tune of around billion dollars. The overall global market for bioterrorism preparedness against smallpox variants is estimated to be several billions of dollars.

The Company anticipates that a successful Phase II clinical trial of NV-387 for the treatment of MPox would open up the US Government SNS market and similar global markets to our drug and benefit the Company's other programs as well.

MPXV Clade Ib strain is dominant in major parts of Africa and continues to spread, whereas the less virulent MPXV Clade IIb strain is dominant in Sierra Leone, with cases increasing at present. While vaccination has started, overall, the uptake of available vaccines has remained lower than anticipated due to logistical, operational, and financial barriers, according to the report of the International Health Regulations (2005) (IHR) Emergency Committee for MPox of the WHO on June 5, 2025.

MPXV Clade II has become epidemic, within limited population demographics, in the Western world including the USA since a 2022 epidemic it caused, driven by travel-related transfer from Western Africa.

The PHEIC regarding MPox 2024 was first declared on August 14, 2024, and was extended in February 2025. It has been extended again now as the MPXV continues to spread in neighboring countries in Africa threatening further global spread and sustained transmission.

ABOUT NANOVIRICIDES

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. 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 currently focused on advancing NV-387 into Phase II human clinical trials.

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 RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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.

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". WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
[email protected]

Public Relations Contact:
[email protected]

View the original press release on ACCESS Newswire

D.Ch. Nadeau--SMC