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Phase II Clinical Trial of NV-387 Oral Gummies as Treatment of Ebola Progressing Well, Says NanoViricides
Phase II Clinical Trial of NV-387 Oral Gummies as Treatment of Ebola Progressing Well, Says NanoViricides
SHELTON, CT / ACCESS Newswire / October 13, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage leader developing antiviral drugs that viruses cannot escape, said today that its Phase IIA Ebola Treatment Clinical Trial of NV-387 Oral Gummies is progressing well.
The Phase IIA part of the clinical trial is designed to evaluate different dosage regimens of the oral gummies for the treatment of different severity levels of the Ebola Bundibugyo virus infection and disease in the current Ebola Outbreak in the Democratic Republic of Congo ("DRC").
The trial is enrolling and is expected to continue enrolling persons exhibiting different disease severity levels, in the "Dry Stage" and "Wet Stage". The clinical symptoms of the Ebola BDBV disease are complex, and possibly different from prior Ebola virus outbreaks, as explained in the footnote i.
Patients are known to come to the Ebola Treatment Centers only when they feel severely ill. Therefore, we are anticipating mostly "Wet Stage" patients, with severe vomiting and diarrhea, to be the primarily enrolled population. Some patients may not be able to take the oral gummies due to vomiting bouts and may be withdrawn; such subjects would not be considered as evaluable if enrolled.
The Phase IIA part of the trial is designed to examine the safety and tolerability of NV-387 oral gummies dosing in the Ebola patients, and the number of days that the drug is tolerated within the context of the disease, starting at 6 days of dosing, and extending by 3 day increments to a maximum of 12 days of treatment. The NV-387 treatment will be stopped when the patient's viral load has become undetectable based on qRT-PCR. Efficacy is not expected to be evaluated in a scientific, statistically significant, manner in such an adaptive treatment scenario. Therefore, and with due ethical consideration, a parallel group of no NV-387 treatment is excluded in this exploratory Phase IIA part.
Nevertheless, an efficacy signal can be seen even in this small clinical trial with up to 20 subjects, if NV-387 is highly effective. This can happen if the data of 20 subjects treated with NV-387 is found to be sufficient to statistically discriminate the NV-387 treated group from the general observations of treatment of Ebola patients in the Ebola Treatment Centers in the same area. Ebola Patients in this area have generally experienced an infection-to-fatality rate (IFR) of 67% to 75%. 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 than the crude Case Fatality Rate (CFR) ii.
The Company will be able to make an announcement regarding (i) whether NV-387 is found to be sufficiently safe and well tolerated to continue into Phase IIB, and, (ii) if NV-387 group is well discriminated from the general expectation of 67-75% IFR, then whether NV-387 oral gummies treatment demonstrated signs of efficacy against the Ebola Bundibugyo virus; after the Phase IIA clinical trial is completed and a report is prepared by the Principal Investigator's team for formal communication.
After an appropriate NV-387 Oral Gummies 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 virological recovery.
The current BDBV outbreak has continued to expand, with 9,000 confirmed cases and 4,339 deaths as of October 10, 2026, according to the WHO iii, with all but a few cases in DRC. An Ebola patient was able to travel from DRC via Uganda to Kenya, and died at home there recently, despite travel restrictions. Fortunately after a week, no secondary infections from this patient have been detected (yet). This emphasizes the potential risk to the world, although the possibility of an Ebola outbreak in the USA or globally remains negligible, because of various global travel restrictions.
Within DRC, 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 iv. 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 v. Additionally, 6 new Ebola cases were recorded in an Eastern part of DRC controlled by rebel groups, further complicating efforts to control the outbreak vi.
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.
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, and even Measles, 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 ix.
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 x. 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.
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.
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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 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.
iii https://www.who.int/emergencies/alert-and-response . Retrieved October 13, 2026: 0205 am EDT.
iv 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.
v https://www.newsmax.com/world/globaltalk/ebola-united-nations-congo/2026/10/02/id/1271553/ .
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.
x 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
W.Fortin--SMC
