The Fort Worth Press - Phase II Clinical Trial of NV-387 as a Treatment for Monkeypox (MPox) Has Begun in DRC, Announces NanoViricides

This clinical trial was registered in the Pan African Clinical Trials Registry database (pactr.samrc.ac.za). The unique identification number for this clinical trial is PACTR202609506749917.

The clinical trial is entitled: "An adaptive international, multi-center, randomized, open-label, interventional, parallel group, phase II (IIa and IIb) clinical trial to evaluate the efficacy and safety of a new chemical entity NV-387 formulated as oral gummies in comparison to standard of care, administered in patients with clinical signs of mpox disease and laboratory confirmed or presumptive hmpxv infection."

The Principal Investigator for this clinical trial is Prof. Vivi Maketa Tevuzula, MD, MSc, PhD, Professor in the Department of Tropical Medicine at the University of Kinshasa and Principal Investigator at the Institut Multisectoriel pour l'Amélioration du Bien-être (IMABE), Kinshasa, DRC. Her work focuses on infectious diseases, including clinical trials demonstrating the safety and efficacy of novel drugs, and safety, immunogenicity, and efficacy of vaccines, as well as health systems research in resource-limited settings. She has served as principal investigator on multiple international studies on malaria, Mpox, and vaccine-preventable diseases, and leads interdisciplinary research on genomic surveillance and One Health approaches.

Bayer Foundation awarded Dr. Vivi Maketa with the prestigious Early Excellence in Science Award 2023 in Medical Science, recognizing her exceptional contributions to the design and implementation of research projects on infectious and neglected tropical diseases ⁱ.

"We are pleased to have Professor Maketa lead this clinical trial," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "This is the very first Phase II clinical trial of the broad-spectrum antiviral drug NV-387 and aims to explore its safety and effectiveness in Mpox."

There is no approved drug for Mpox. Clinical trials of a drug called tecovirimat (TPOXX, SIGA) have previously failed to demonstrate efficacy against both Mpox Clade II and Mpox Clade I. Tecovirimat was approved by US FDA for Smallpox under the Animal Rule provision.

A pan-African clinical trial called "MOSA" of a drug called brincidofovir, which is approved by US FDA for Smallpox under the Animal Rule provision, that started in January, 2025, is currently ongoing. As of January 2026, according to a press release, this study's Data Safety and Monitoring Board (DSMB) did not identify any new safety concern after the first 50 patients were randomized, and the trial plans to enrol a further 50 patients in the first half of 2026, to perform interim efficacy analysis of brincidofovir ⁱⁱ. Brincidofovir requires constant physician care due to dose-limiting liver and gastro-intestinal toxicity concerns ⁱⁱⁱ.

NV-387 could become the "go to" pandemic response drug if it is successful in this Phase II MPox clinical trial, and becomes a FDA-licensed (approved) drug. US Government SNS stockpiling contracts for existing smallpox drugs TPOXX and TEMBEXA have been in several hundreds of millions of dollars, representing an equivalent potential opportunity for NV-387.

The Phase II clinical trial for NV-387 as a treatment of mpox is being conducted at Lodja in Sankuru province in DRC. As of now, this province is not an ebola-affected region.

Professor Maketa's team is already on site in DRC. In addition, The team of our CRO from India, Om Sai Clinical Research Pvt. Ltd., is also on site in DRC to start the clinical trial.

Lodja is a remote location and mpox cases are continuing to occur in that area. This is a resource-poor region. Setting up the clinical sites required several months of effort because of the resource limitations at the hospital.

MPox Clade I is endemic in DRC and all cases in the clinical trial are expected to be of the Clade I virus. The other prominent MPox virus, MPox Clade II is substantially less severe an infection than MPox Clade I.

MPox Clade II has become endemic in the USA, circulating at low levels. It primarily affects a limited population of Men-having-Sex-with-Men (MSM), because of transmission during sexual activity.

MPox is an "Orphan Disease" in the USA. NanoViricides has applied to the US FDA for Orphan Drug Designation (ODD) of NV-387 for the treatment of MPox. This ODD, assuming it is granted, would enable several benefits including frequent meetings with FDA, waiver of certain FDA fees, certain R&D credits, as well as extension in exclusivity in marketing once approved.

These ODD benefits can have a positive economic impact for NanoViricides estimated in the range of tens of millions of dollars.

MPox Clade I cases in the USA have been slowly increasing. As of August 27, 2026, since November 2024, there have been more than 50 confirmed cases of Mpox Clade I in the USA, all of which were either travelers to Mpox-manifesting countries or regions, or contacts of such travelers, according to the CDC ^iv. Community spread of the MPXV Clade I is likely occurring, with 3 cases of MPox Clade I with no travel to Africa, in California in unconnected persons, according to the CDC ^v. However, the potential for a widespread outbreak remains low.

From 2023-2025, about 1,700-2,800 cases of Mpox Clade II were confirmed in the USA, mostly occurring in men-having-sex-with men and associated sexual partners, according to the CDC (ibid #4). Clade II is transmitted via skin abrasions.

Thus MPox is becoming important in the USA from the perspective of pandemic preparedness and response. Although there is a vaccine originally developed for smallpox, namely, Jynneos, that is in use to prevent MPox (primarily in clade II contacts), its immune protection was found to wane rapidly in a clinical study ^vi. The effectiveness of this vaccine is limited, at 36% for one dose and 66% for 2 doses against the less pathogenic MPox Clade II ^vii.

The vaccine effectiveness is likely to be much less against the more severe MPox Clade I.

Vaccines do not protect in the first few weeks, limiting their usefulness during pandemic.

We believe that there will be a strong opportunity for NV-387 for pandemic preparedness and response for the threats of Mpox and Smallpox in the USA if this Phase II clinical trial of NV-387 for the treatment of Mpox is successful. The two drugs in the USA Strategic National Stockpile (SNS), TPOXX and TEMBEXA, would be unsuitable for pandemic response if MPox Clade I spreads. Although both of these drugs are approved for Smallpox, a bioterrorism agent, under the FDA animal rule, the clinical trial failure of tecovirimat against Mpox which is a much less severe and far less lethal disease compared to Smallpox raises questions about its possible utility in a Smallpox bioterrorism event. In addition, the known toxicity profile and warnings for brincidofovir make it unsuitable for wide-scale deployment in a large outbreak scenario.

"NV-387, our broad-spectrum antiviral drug is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases," said Anil R. Diwan, Ph.D., adding "NV-387 is designed to mimic human cells to trap and destroy the virus. This single drug can target over 90-95% of human pathogenic viruses due to this biomimicry, which is reminiscent of the antibiotic penicillin that targets a large number of human pathogenic bacteria."

NV-387 was found to possess strong antiviral activity against an orthopoxvirus in an animal model that is considered an important model to establish potential effectiveness against MPox and Smallpox viruses, as all of these viruses belong to the same family of orthopoxviruses.

In fact, NV-387 effectiveness matched the effectiveness of the small chemical drug tecovirimat in two different models of infection, one was direct skin infection, and the other was a direct lung infection, by the virus.

Escape of virus from tecovirimat is known to occur by a single point mutation in a viral protein called VP-37.

Vaccines, antibodies, and small chemical drugs such as tecovirimat for MPox/Smallpox, or oseltamivir (Tamiflu^®), baloxavir (Xofluza^®) for Influenza are readily escaped by viruses simply by introduction of small changes that viruses undergo when they are faced with these challenges in the field.

In contrast, escape of virus from NV-387 is highly unlikely because no matter how much the virus changes in the field, it continues to use sulfated proteoglycans such as HSPG as "attachment receptor" in order to cause cell infection. NV-387 mimics the sulfated proteoglycan signature feature that the viruses require.

NV-387 is a host-mimetic drug that "looks like a cell" to the virus, displaying numerous ligands that mimic the sulfated proteoglycan, enticing the virus to bind to and become engulfed by the NV-387 dynamic shape-shifting polymeric micelle.

Therefore development of NV-387, a broad-spectrum host-mimetic, direct-acting antiviral drug that the viruses cannot escape even as they change constantly, will be revolutionary once the drug undergoes regulatory development for approval for use in humans.

New viruses and existing viruses acquiring greater pathology and infectivity are bound to keep appearing in time. To combat such threats, we need to develop broad-spectrum drug arsenal that the viruses cannot escape. Vaccines and antibodies simply will not do, and their limitations have become clearly evident during the COVID-19 pandemic.

About NanoViricides

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a 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.

NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. 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 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.

Where stated with an ^® , the name is a registered trademark, which belongs to the owner of the trademark name.

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.
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i https://www.bayer-foundation.com/lets-spotlight-our-science-talents-dr-vivi-maketa

ii https://mpx-response.eu/a-first-safety-interim-analysis-of-mosa-shows-no-signal-of-safety-concerns-with-brincidofovir-a-potential-antiviral-to-fight-mpox/

iii According to the drug label (prescribing information), brincidofovir ("TEMBEXA") carries a black box warning, and has warnings for elevations in hepatic transaminases and bilirubin (liver toxicity) and diarrhea and other gastrointestinal adverse events. Brincidofovir administration must be performed under physician care with continuous evaluation of liver toxicity.

iv https://www.cdc.gov/monkeypox/situation-summary/index.html

v https://www.aha.org/news/headline/2025-10-29-cdc-says-3-cases-severe-mpox-california-may-be-linked-august-case

vi https://www.cidrap.umn.edu/mpox/amid-new-mpox-outbreak-study-suggests-waning-protection-jynneos-vaccine

vii From the Mpox Emergency Response Team, CDC (2023-05) "Vaccine Effectiveness of JYNNEOS against Mpox Disease in the United States," N Engl J Med 2023;388:2434-43.

SOURCE: NanoViricides

View the original press release on ACCESS Newswire

H.M.Hernandez--TFWP