SHELTON, CT /
ACCESS Newswire
/ October 27, 2026 /
NanoViricides, Inc. (NYSE American:
NNVC
) (the "Company"), a clinical stage leader developing antiviral drugs that viruses cannot escape, explained today that the Phase IIA Ebola Treatment Clinical Trial of NV-387 Oral Gummies is progressing well, and the drug is expected to advance into the Phase IIB clinical trial part as soon as the Phase IIA part is completed.
"The importance of the NV-387 Oral Gummies treatment for this Ebola Bundibugyo virus disease cannot be understated, considering the potential of the disease for rapid spread and the heavy toll it is taking in affected areas in terms of both deaths and economic costs of containment and response," said Anil R. Diwan, PhD, President and Executive Chairman of the Company.
The NV-387 Oral Gummies as a Treatment for Ebola Phase II Clinical Trial in DRC is divided into two parts. The first part, Phase IIA, is designed to evaluate dosing regimens based on the severity of the disease, and requires approximately 20 patients. Enrollment began on September, 23, 2026. The end point is 28-day survival, as with other Ebola clinical trials. As such, the Phase IIA part will be completed once the last enrolled person completes 28 days.
The course of the clinical trial suggests that the trial will continue into Phase IIB part upon completion of the Phase IIA part.
Ebola has escaped the main epidemic affected country of Democratic Republic Congo (DRC) in multiple instances, and cases have started occurring in Kenya as well as Nigeria, one of the most populous countries in Africa
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. Previously, an infected person had traveled from DRC to Uganda, causing a small outbreak, but there have been no new cases reported in Uganda recently. A person that traveled recently from DRC to Kenya died, and infected at least 8 others, one of whom has also died, and at least 134 contacts were traced
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. Kenya has released some of the quarantined contacts. The case in Nigeria was a Swiss national and was evacuated to a Swiss hospital for treatment. Previously, medical personnel working with the Doctors Without Borders (MSF/DWB) have been evacuated to Europe for treatment.
This East to West Africa spread has occurred in spite of substantive travel restrictions. Additional restrictions have been effected by many countries as a result
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. Importantly, the instances of single infected persons creating multiple cases have demonstrated the significant global risk and challenge posed by this Ebola outbreak. As many as 8 or more cases have occurred from contact with a single infected person during this outbreak. Such persons causing a large number of transmissions are often called "superspreaders".
As the outbreak continues, the number of confirmed cases in DRC have reached 10,060, with 4,887 deaths since this Ebola-Bundibugyo virus outbreak was identified. It is the fastest growing Ebola outbreak, and largest in DRC, with the potential to eclipse, in a few months, the West Africa 2014-16 Ebola-Zaire outbreak that killed 11,000 people.
A clinical trial of Infusions of an antibody cocktail, Infusion of remdesivir, and Infusion of both of them given to the patient is in progress, called the "PARTNERS" clinical trial, since July 2, 2026. There have been no public updates, other than that more than 350 patients were already enrolled about a month ago.
A clinical trial to evaluate vaccines, called "Tumaini" (meaning "Hope" in Swahili) has started as of last week. The first candidate vaccine in this trial is Ervebo, which is specific to Ebola Zaire, and it is not known how effective it could be against Ebola Bundibugyo virus. Two other vaccine candidates, one developed by University of Oxford, ChAdOx1-BDBV, and another, a BDBV-mRNA vaccine developed by Moderna, are expected to be added into this clinical trial when the supplies become available
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. This vaccines trial will employ a "ring vaccination" protocol.
Ervebo vaccine is not specific to BDBV, which means it is an unmatched vaccine. Unmatched vaccines can cause rapid occurrence of escape mutants. Also, in vaccinated persons, later infection can even cause a more aggressive disease, a phenomenon called "Antibody-Dependent Enhancement" of disease, promoted by the inaccurate antibodies created in response to the vaccine. Vaccines in general can lead to escape mutants. Ebola virus is an RNA virus and thus very capable of generating escape mutants.
Vaccines are not useful for a person after infection. Also, a vaccine requires about 2-3 weeks for antibody response to be generated, and therefore is minimally protective before 3 weeks. If a second dose of vaccine is needed, it complicates the situation further, because the first dose only creates partial immunity.
Thus an effective treatment is essential for combating a spreading epidemic such as the current Ebola epidemic. Infusions such as of antibody cocktails or small chemical drugs are only useful, if effective, when patients can be hospitalized for the duration until recovery, and are costly to store, transport, and administer. Thus, to combat a widely spreading disease in the community, oral drugs are the most preferred.
There is no treatment or vaccine approved for Ebola BDBV at present. NV-387 Oral Gummies is the only oral drug product in clinical trials, to the best of our knowledge, underscoring its importance for fighting the current Ebola BDBV epidemic, and future epidemics.
The same drug product, NV-387 Oral Gummies, is also in a Phase II clinical trial for the treatment of Mpox (Monkeypox) in DRC.
NV-387 is a novel, revolutionary broad-spectrum antiviral that is poised to change the way humanity treats viral infections.
ABOUT NANOVIRICIDES
NanoViricides, Inc. (the "Company") (
) 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.
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.
info@nanoviricides.com
Public Relations Contact:
ir@nanoviricides.com
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SOURCE:
NanoViricides
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