The Fort Worth Press - NanoViricides Has Received Regulatory Approval for a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for Ebola in DR Congo To Fight the Current Largest Ever and Expanding Ebola Outbreak

NanoViricides has retained Om Sai Clinical Research Private Limited, India, (Om Sai CRO) as the CRO for this Phase II clinical trial for Ebola in DRC. Om Sai CRO has been instrumental in putting together a team with a renowned Principal Investigator and other renowned experts and with support from a well known University in the Ebola-affected region to lead and execute the clinical trial of NV-387 Oral Gummies as a Treatment for Ebola viruses in DRC.

The Principal Investigator (PI) sent in the application for the clinical trial to ACOREP which has now been approved. The PI, with the DRC team, has already been performing initial preparations in anticipation of the clinical trial approval, in order to speed up the date to the first dosing of patients.

"We believe NanoViricides is well positioned to provide an Oral Ebola treatment to save lives with our NV-387 Oral Gummies drug product that is already in place in DRC," said Anil R. Diwan, PhD, President of the Company, adding, "This unique and revolutionary oral broad-spectrum antiviral drug will now be tested in a clinical trial, and we thank all involved in making this possible."

The current Ebola Virus Disease (EVD) caused by the Bundibogyo ebolavirus (BDBV) is now the largest ever ebola outbreak in DRC. As of August 6, 2026, there have been 4,141 confirmed cases and 1,889 confirmed deaths due to this virus. Only 829 confirmed cases have been reported to have recovered from the disease. The crude fatality rate (crude CFR) is 46%, according to the WHO¹. The outbreak continues to grow, and during the most recent complete reporting week, the highest weekly number of reported cases (567) and deaths (296) to date were recorded, according to the WHO². Reportedly, "(it) is spreading like a wildfire"³.

This Ebola outbreak continues to increase in spread and is now present in at least five provinces in DRC⁴. More concerning is the fact that over 80% of new cases are outside of known contact lists, leading to the projection that the extent of the outbreak is at least two times or more larger than the reported confirmed cases⁵. Additionally, Ebola is now found to have spread into displacement camps that host over 4.4 million displaced persons due to internal warfare, adding another high risk population pool with poor drinking water, sanitation and medical resources to further fuel this outbreak, according to the UN New Service⁶.

There is thus a tremendous urgency to validate a drug that works against this ebolavirus in short and decisive clinical trials for minimizing further spread by treating patients and for saving lives. Om Sai CRO, in consultation with renowned scientists in DRC, has designed the Phase II clinical trial with this particular objective.

In contrast, the PARTNERS clinical trial (see below) will require over 1,000 patients to be treated and may not yield results for at least more than a year. A similar large collaborative clinical trial effort in the West Africa outbreak resulted in US FDA approval of two antibody drugs only specifically for EBOV Zaire, which are not deemed to be useful in the current outbreak without further clinical trials.

NV-387 is the only orally active agent under consideration for clinical trial as a treatment of Ebola to the best of our knowledge. In an epidemic scenario in resource limited settings such as in DRC, we believe an oral drug is a highly advantageous feature.

Other treatments under consideration require infusions. Infusions are difficult to implement and also are not scalable in a large outbreak scenario such as this Ebola virus outbreak if it continues to grow, as has been widely expected.

A clinical trial, called the "PARTNERS" clinical trial, evaluating Remdesivir infusion, an antibody cocktail MBP134 infusion, and MBP134 infusion plus Remdesivir infusion, has started according to WHO with first patient having received infusion of the antibody cocktail on July 2, 2026⁷.

"Although this antiviral (Remdesivir) proved to be ineffective at targeting the Zaire Ebolavirus, there remains hope that it could have some benefit against the Bundibugyo virus, particularly if used in combination with MBP-134," according to an article in Forbes explaining the "PARTNERS" clinical trial by the WHO organized collaboration⁸. The article also notes that MBP134 contains two separate antibodies designed to, taken together, recognize multiple Ebola species.

Antibodies are highly specific to a particular strain of the virus and usually are not very effective against variants of the same virus that arise in the field. Viruses also escape antibodies readily by mutations in the field.

The Company notes that NV-387 was previously found to be superior to Remdesivir in a lethal animal model of a viral disease. The Company believes this superiority of NV-387 is reasonably expected to extend to the current novel Bundibugyo ebolavirus strain.

There is no approved Treatment or Vaccine for the new variant of the Bundibugyo Ebolavirus (BDBV) that is causing the current rapidly expanding outbreak of the Ebolavirus Disease (EVD) in DRC. The rare Bundibugyo strain of Ebola virus causing the current outbreak appears to be its new variant, likely freshly introduced from some animal source⁹, such as fruit bats.

A new clinical trial of an Oxford University designed Bundibugyo-specific vaccine has also started in DRC, in addition to the treatment trials of antibody and remdesivir infusions (ibid, #8). Further, Ervebo, a vaccine approved for Ebolavirus Zaire, may also enter clinical trials for the protection of uninfected persons from the distinctly different Bundibugyo ebolavirus due to the enormity of the emergency posed by the current outbreak despite reservations regarding a potentially imperfect vaccine¹⁰.

Om Sai is the CRO leading the Company's Phase II clinical trial of NV-387 Oral Gummies as a Treatment for Mpox in DRC, and the same CRO is also leading the newly approved Ebola clinical trial.

Sufficient quantity of NV-387 Oral Gummies Drug Product for starting the clinical trial against Ebola is already available in DRC. This drug product was shipped to DRC for the ensuing Phase II clinical trial of NV-387 for the Treatment of Mpox and also to support the Phase II clinical trial for the Treatment of Ebola only upon approval by the regulatory agency, which has now been approved.

"We believe NV-387 could be revolutionary in this fight against Ebola, if it is found to be effective," said Anil R. Diwan, PhD, adding, "It is an oral drug, in contrast to others that are infusions. Thus evaluating if NV-387 treatment works is of paramount importance to combat this and future Ebola and Marburg outbreaks."

NV-387 is a broad-spectrum antiviral that mimics the host-side features that the virus requires, and is likely to be effective against Ebola viruses because they use the same host-side feature mimicked by NV-387.

It is highly unlikely that viruses can escape NV-387, because this drug mimics the features on host cells that the viruses continue to require even as they mutate or evolve in the field.

Additionally, NV-387 Oral Gummies is a drug product readily delivered orally. It does not even require swallowing effort or water, because it dissolves in the mouth by itself, simplifying delivery for even sick individuals with swallowing difficulties.

This oral delivery is an important feature that puts NV-387, a broad-spectrum antiviral, as being superior to the other approaches.

"Only safe and effective broad-spectrum antiviral drugs like NV-387 that can effectively tackle most viral infections will enable the world to combat viruses and defend the global population in the war against known and unknown nanoscopic enemies that are viruses," commented Dr. Diwan, adding, "Today, NV-387 is the only drug in clinical development with such broad-spectrum potential that promises to combat diverse epidemics like Mpox and Ebola, to the best of our knowledge."

While there is currently minimal risk of Ebola in the USA, the CDC's mathematical models suggested this Central African outbreak could grow to 10,000 to 20,000 cases and 2,000 to 4,000 deaths within just three months, rivaling the largest outbreak to date in 2014-2016¹¹. Unfortunately, the outbreak appears to be even more aggressive than the CDC model, with close to 2,000 deaths in less than three months, over 4,000 confirmed cases, and over 10,000 estimated total cases¹².

The outbreak which was declared a Public Health Emergency of International Concern ("PHEIC") by the WHO on May 17, 2026, continues to rapidly expand, outpacing containment efforts. The outbreak arose in a high traffic region bordering the Democratic Republic of Congo (DRC), with travel contacts to Uganda, and South Sudan and with 11 more nations in Africa at risk¹³.

NV-387 is a broad-spectrum antiviral that mimics the host-side feature called heparan sulfate proteoglycan (HSPG) that over 90-95% of human pathogenic viruses require for infecting cells. No matter how much the virus changes in the field, it continues to use HSPG, and therefore it cannot escape the drug NV-387. In contrast, Remdesivir is a small molecule inhibitor of the viral RDRP enzyme needed for making copies of the viral genome, and the virus can possibly escape by small number of mutations.

All Ebola viruses utilize HSPG as the attachment receptor prior to gaining entry into the cell. Thereafter, followed by entry into the cell inside endosomes, the ebolavirus surface glycoprotein is substantially degraded, opening up its site for binding to its cognate receptor called NPC1, thereby entering into the cytoplasm where the next steps in its replication begin.

Thus there is a strong rationale that NV-387 could be highly effective against Ebola virus infections, not just Bundibugyo, but also the Sudan and other viruses for which there are no treatments.

NV-387 is available as an oral medication that has excellent stability at room temperature, enabling ease of transport, distribution, and delivery to patient. NV-387 oral gummies dissolve naturally in the mouth and do not require tablet swallowing, which is difficult for children, seniors, and also patients with sore throat.

All previous anti-Ebola efforts have been focused on vaccines and antibodies¹⁴. This has led to approval of therapies that are specific to the Ebolavirus Zaire strain only, albeit with limited effectiveness. This leaves out all other filoviruses of consequence: Sudan, Marburg, and the more rare Bundibugyo with no treatment or vaccine.

In contrast, if NV-387, as a broad-spectrum antiviral, is found to be effective against the Bundibugyo virus, it will likely be effective against all ebolaviruses and possibly all filoviruses; that would be a game changer for pandemic preparedness.

The case fatality rate of ebolaviruses has generally been approximately 50% in recent outbreaks, with improvements in care, including hydration therapy, corticosteroids, and other usual symptomatic treatments. Ebola viruses spread via bodily fluid secretions including fomites/sputum, as well as semen/genital secretions. Ebola virus can remain in survivors even as many as 965 days after the disease without symptoms, and can transmit through bodily secretions, suggesting possible latency. Many recent outbreaks have been ignited as a result of such reawakened-transmitted virus from a survivor. Sexual transmission was documented even as late as 482 days after disease. This persistence and possible latency of ebolavirus in immune-privileged organs (e.g. brain, eyes, gonads, where antibodies are not operative) makes it a uniquely serious threat for global transmission and sustained outbreaks.

So far, BDBV has demonstrated variable CFR ranging from under 15% (in Uganda, 2026), to 46% (in DRC, based on current confirmed cases and fatalities numbers, as of August 6, 2026). Therefore, BDBV is of great concern as a potential pandemic disease. However, it is believed that ebolaviruses do not transmit via respiratory droplets or aerosols and rather require extensive contact with bodily fluids of an infected person. In addition, within DRC and internationally, certain protective quarantine measures for travel from the outbreak areas have been implemented. Therefore, currently there is no apparent threat of a global pandemic.

An irony is that because of the high case fatality rate (CFR) approaching 50%, the spread of ebolaviruses remains rather limited. If a variant emerges with a reduced CFR, say in the range of 5-15%, the potential threat of global pandemic from such an outbreak would increase substantially.

With ever-increasing global travel, local outbreaks such as ebola can quickly travel far and wide potentially causing global pandemics, as was the case with COVID-19, if not caught in time. It is not feasible to produce a new vaccine and a new set of antibody drugs to combat every possible virus. Even if vaccines and antibodies are produced, the virus would escape by generating variants, as the world has witnessed during the COVID-19 pandemic.

The US Government is active in ensuring that suspected or confirmed ebolavirus cases do not enter the general population in the USA. To this end, travel from DRC has been restricted, with pre-travel quarantine requirements imposed, and suspect travelers are directed to screening at specific airports and may be further quarantined.

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.

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]

⁴ https://www.aljazeera.com/news/2026/7/20/ebola-death-toll-in-drc-surges-to-at-least-930-as-outbreak-gathers-pace

https://www.aljazeera.com/news/2026/7/16/ebola-spreading-more-quickly-in-drc-while-uganda-is-close-to-being-virus-free

View the original press release on ACCESS Newswire

J.Ayala--TFWP