London
20 °C
Manchester
Glasgow
Dublin
Belfast
Washington
Denver
14 °C
Atlanta
Dallas
Houston Texas
22 °C
New Orleans
El Paso
Phoenix
Los Angeles
6 °C
13 °C
6 °C
14 °C
27 °C
NanoViricides Provides Additional Details on the Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for Ebola as the Outbreak Continues to Expand and Has Taken Over 4,000 Lives
NanoViricides Provides Additional Details on the Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for Ebola as the Outbreak Continues to Expand and Has Taken Over 4,000 Lives
SHELTON, CT / ACCESS Newswire / October 5, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage leader developing antiviral drugs that viruses cannot escape, herewith provides additional details on its Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for the Current Bundibugyo Ebolavirus (BDBV) and other Ebola viruses in the Democratic Republic of Congo ("DRC").
The trial is proceeding as designed. This clinical trial is being conducted in two parts. Enrollment in the first part, Phase IIA, began on or about September 23, 2026. Patients are being enrolled slowly, in a cautious approach, because NV-387 is a new chemical entity. As the clinical experience with NV-387 increases, enrollment may speed up. This part requires only a small number of patients.
In Phase IIA, the trial is designed to evaluate the dosage regimen that is tolerable in patients with clinical Ebola Virus Disease (EVD). The purpose of the Phase IIA part is to determine the optimal dosing regimen (amount, frequency, and schedule in number of days) that remains well tolerated in terms of safety signals (toxicity) in the context of the issues caused by the Ebola Bundibugyo viral disease itself. The clinical symptoms of the Ebola BDBV disease are complex, and possibly different from prior Ebola virus outbreaks i.
It is expected that when the optimal dosage regimen is administered, signs of reduction in viral load would be seen, and potentially, recovery in the patients would also be seen. However, the Phase IIA part is not designed for evaluating efficacy of the drug in a statistical sense. It is designed to provide a quick go-nogo gate to support starting the Phase IIB, which is a randomized clinical trial of NV-387 Oral Gummies designed for evaluating efficacy in treating Ebola patients.
After a dosage regimen is identified, it will be used in an expanded, randomized, controlled clinical trial, Part IIB, to evaluate effectiveness of the Oral treatment drug NV-387 Oral Gummies.
NV-387 is designed to attack the virus and reduce the viral load in the body.
Reducing viral load correlates with improvement in physiological function. Reduction in viral load to undetected level means complete recovery from the viral disease. However, the bodily functions, may take longer time even after reaching undetectable viral load, as the virus-attacked organs rejuvenate. It is also possible that some permanent damage, e.g. kidney damage, may persist even after viral recovery.
The current BDBV outbreak has continued to expand, and while the initial outbreak sites including Ituri have possibly stabilized, the outbreak has started gaining strength in Nord Kivu province with 40% of national confirmed cases now coming from Nord Kivu, which does not have sufficient ebola treatment centers capacity, with only 29 beds in treatment center, and only about 20 "transit facility" beds for holding suspected cases until diagnosis results come in, according to Doctors Without Borders ii. Recently, thousands of refugees fled from a refugee camp where more than 30 people had died from Ebola BDBV, to escape from security forces that were investigating weapons stored in the camp. Their fleeing has increased the risk of spread iii. Additionally, 6 new Ebola cases were recorded in an Eastern part of DRC controlled by rebel groups, further complicating efforts to control the outbreak iv.
The death toll has now risen to 4,018, and confirmed cases have gone up to 8,300 making this the fastest rising Ebola virus outbreak in the whole world, as of the data released on October 2, 2026, by the DRC government v. The crude case fatality rate (CFR) remains at about 48%, and the infection-to-fatality (IFR) rate remains at about 67%. The IFR corrects the data for the fact that the infected person dies on an average about three weeks later, and therefore is a more accurate representation of reality vi.
NV-387, as an oral medicine to treat the BDBV disease would be highly valuable to counter and control this BDBV Ebola outbreak, if it is found to be effective in this clinical trial. A clinical trial of oral pill obeldesivir, as a post-exposure prophylaxis (not treatment), in persons that have contact with a case but do not have symptoms, has been ongoing since July, 2026. Obeldesivir has previously failed in a clinical trial for SARS-CoV-2.
The "PARTNERS" clinical trial that started in July, 2026, is evaluating (1) Infusion of an antibody cocktail MBP134, (2) Infusion of Remdesivir, and (3) Infusion of MBP134 together with Infusion of Remdesivir. Infusions are risky with a lethal disease such as Ebola, and are difficult to implement and scale to combat the current expanding outbreak in resource-limited settings.
In contrast, NV-387 Oral Gummies can be readily deployed even in the remotest parts to combat this outbreak, if successful.
Antibodies can result in the virus mutating away and escaping the drug, making the antibodies useless, as repeatedly seen during COVID-19. NV-387 relies on a unique host-side feature that all viruses still require and use no matter how much they change in the field. Therefore, it is highly unlikely that the virus can escape NV-387.
The USA has been, laudably, and proudly, the largest provider of humanitarian and relief assistance in this outbreak, with almost $1.4 Billion in contributions. The USA has already provided $887 Million, and has pledged another $500 Million, of which $267 million has been released, according to the US Department of State vii.
There is no current threat of Ebola in the USA. 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.
Travelers going to and from Central Africa need to constantly check travel restrictions as well as travel limitations in light of these changing outbreak conditions. It is apparent that travel restrictions have been able to control the outbreak periphery to DRC alone (with few early cases in Uganda) minimizing risk to the rest of the world.
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 source viii, such as fruit bats.
"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 collaboration ix. 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.
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.
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."
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 risk x.
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.
All previous anti-Ebola efforts have been focused on vaccines and antibodies xi. 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.
At present, BDBV has been consistently demonstrating high crude CFR of 48% and IFR of 67% in DRC. 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.
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.
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]
i Clinical Symptoms of Ebola BDBV
It is thought that it may take several days after contact with a patient's bodily fluids for the infected person to develop initial symptoms. These symptoms involve fever, headache, muscle aches and pains, and fatigue, called the "Dry Stage" symptoms. They are similar to other prevalent diseases including malaria and typhoid fever. These symptoms may last from a few days to about a week. Thereafter, the disease progresses to the "Wet Stage", which is characterized by explosive vomiting and severe diarrhea. Anyone who comes in contact with the bodily fluids including caretakers, family members, friends, and healthcare workers, can get infected.
In the Wet Stage, the viral load keeps increasing and multi-organ failure begins progressively, and later, all of a sudden, extensive failure occurs and the patient becomes critical. There is very little possibility that a critical stage patient can survive despite all possible clinical efforts.
Some patients can respond to aggressive treatment during the Wet Phase and enter a recovery phase. Even after the viral load becomes undetectable, and the patient is discharged, overall systemic recovery takes a long time as the bodily systems need to rejuvenate. Some permanent damage such as partial or total kidney failure can occur.
BDBV primarily and severely affects the liver function, kidney function, and the blood system function, in addition to the gastrointestinal system. Its effects on the coagulation system can lead to hemorrhages in some but not all patients.
ii https://www.doctorswithoutborders.org/latest/ebola-outbreak-spreading-wildfire-across-north-kivu October 2, 2026. The Ebola Treatment Centers (ETC) are specially designed, temporarily erected wards with extreme patient isolation and personal-protective-equipment (PPE) protocols, outside hospitals, where the Ebola confirmed cases are admitted and treated. A person with symptoms is first taken into an Ebola Transit Facility, with less isolation. A blood sample is taken and sent for testing. If the RT-PCR result is positive for Ebola virus, then the person is admitted into the nearby ETC.
iii https://www.newsmax.com/world/globaltalk/ebola-united-nations-congo/2026/10/02/id/1271553/ .
vi Crude CFR is easy to calculate but IFR is a more accurate measure of probability of death.
The Crude CFR is calculated simply by dividing the confirmed deaths by the confirmed number of cases on the same reporting date. It ignores the fact that the deaths are actually occurring in patients that were confirmed infected several days earlier; i.e. the time lag of sickness is not accounted for in the crude CFR. If it is accounted for, the actual fatality rate per confirmed infection (Infected Fatality Rate or IFR) would be much higher than the crude CFR. For example, if one assumes an average time lag of 21 days (Aug 14 to Sept 5), then the IFR on September 5 would be (3,175/4,945 = ) 64%. Not all infections are reported or confirmed by lab tests; however, it is likely that most deaths are counted. This produces a large uncertainty in such CFR and IFR estimates. Another way to estimate IFR would be to simply take a ratio of confirmed deaths to that of confirmed deaths plus confirmed recoveries. This metric, probability of death, is more robust and insensitive to the lag times, except it ignores patients that are still in hospital. The p(death) based on this metric is (using Sept. 10 numbers,(3,398)/(3,398 +1,671) = 67% . That said, a number of cases as well as deaths remain unconfirmed or unreported because of the regional issues.
vii https://www.state.gov/releases/office-of-the-spokesman/2026/09/united-states-pledges-additional-life-saving-health-assistance-in-response-to-ebola-outbreak/. September 23, 2026.
xi Substantial work was also performed to develop small chemical potentially broad-spectrum agents. Remdesivir was the only small chemical that entered the PALM clinical trials ca. 2018-2019 but failed to show effectiveness. Small chemicals are readily escaped by viruses often with just single mutations.
SOURCE: NanoViricides
View the original press release on ACCESS Newswire
(E.Taylor--TAG)
