NanoViricides, Inc. (NYSE American: NNVC) said its Phase IIA clinical trial of NV-387 Oral Gummies for Ebola Bundibugyo virus disease is progressing in the Democratic Republic of Congo (DRC). The company said the trial is expected to move into its Phase IIB portion once the Phase IIA stage has been completed.
#Trial design and timing
The Phase II programme is split into Phase IIA and Phase IIB. According to NanoViricides, the first stage is intended to assess dosing regimens according to disease severity and requires approximately 20 patients.
Enrollment began on September, 23, 2026. The trial uses 28-day survival as its endpoint. NanoViricides said the Phase IIA stage will finish after the last enrolled participant has completed 28 days, after which the trial is expected to continue into Phase IIB.
#Company comments on the Ebola outbreak
NanoViricides said Ebola had spread from the DRC to Kenya and Nigeria, while no new cases had recently been reported in Uganda. The company reported that confirmed cases in the DRC had reached 10,060, with 4,887 deaths since the Ebola-Bundibugyo virus outbreak was identified.
The company also said individual infected people had been linked to multiple additional cases during the outbreak, including instances involving 8 or more transmissions. It described the outbreak as a major challenge despite travel restrictions and additional measures introduced by several countries.
Anil R. Diwan, NanoViricides’ President and Executive Chairman, said the company considers an oral treatment important because of the disease’s potential to spread rapidly and the deaths and economic costs associated with containment and response.
#Current treatment and vaccine context
NanoViricides said no treatment or vaccine for Ebola Bundibugyo virus disease had been approved at the time of the announcement. The company described NV-387 Oral Gummies as, to the best of its knowledge, the only oral drug product in clinical trials for the disease.
The company said the PARTNERS trial, involving infusions of an antibody cocktail, remdesivir, or both, had been underway since July 2, 2026. It also said the Tumaini vaccine trial had started as of last week. The first candidate identified for that study was Ervebo, which is specific to Ebola Zaire, and NanoViricides said its effectiveness against Ebola Bundibugyo virus was not known. Two additional candidates were expected to be added when supplies became available: ChAdOx1-BDBV, developed by the University of Oxford, and a BDBV-mRNA vaccine developed by Moderna.
NanoViricides said vaccines are not useful after infection and that antibody responses take about 2-3 weeks to develop. The company argued that oral medicines may be more suitable for treating a disease that is spreading through communities, while noting that infused treatments require hospitalisation until recovery and can be costly to store, transport and administer.
#Other NV-387 development work
NV-387 Oral Gummies is also being studied in a Phase II clinical trial for Mpox, or Monkeypox, in the DRC. NanoViricides identified NV-387 as its lead drug candidate and said it plans to develop the drug for RSV, COVID, Long COVID, Influenza, other respiratory viral infections and MPOX/Smallpox infections.
The company’s other advanced candidate is NV-HHV-1 for Shingles. NanoViricides said it is also developing programmes for several other viral diseases, including oral and genital Herpes, viral diseases of the eye, HIV, Hepatitis C, Rabies, Dengue fever and Ebola virus.
#Company platform and development risks
NanoViricides is a clinical-stage company developing special-purpose nanomaterials for antiviral therapy. Its nanoviricide drug candidates and technology are based on intellectual property, technology and proprietary know-how licensed from TheraCour Pharma, Inc. The company said its business model is based on licensing technology from TheraCour for specific applications involving particular viruses.
NanoViricides cautioned that pharmaceutical development is extremely lengthy and requires substantial capital. It said there is no assurance that its candidates will demonstrate sufficient effectiveness and safety for human clinical development. The company also identified risks related to clinical development, regulatory approvals, commercialisation and market acceptance, and said actual events could differ materially and substantially from its forward-looking statements.
#Key Takeaways
- NanoViricides said the Phase IIA NV-387 Oral Gummies Ebola trial in the DRC is progressing toward a Phase IIB stage.
- Phase IIA is designed to assess dosing regimens by disease severity and requires approximately 20 patients.
- The trial’s endpoint is 28-day survival, with Phase IIA ending after the last participant completes 28 days.
- The company reported 10,060 confirmed DRC cases and 4,887 deaths since the Ebola-Bundibugyo virus outbreak was identified.
- NanoViricides said NV-387 Oral Gummies is also in a Phase II Mpox clinical trial in the DRC and warned that its drug-development programme carries substantial time, capital, safety and regulatory risks.
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