NanoViricides, Inc. has provided additional details on its Phase II clinical trial of NV-387 Oral Gummies for patients with Bundibugyo Ebolavirus and other Ebola viruses in the Democratic Republic of Congo. The company said the study is advancing as planned, with enrolment in its initial Phase IIA stage beginning on or about September 23, 2026.
#Two-stage clinical trial
The first stage is intended to identify a dosage regimen that patients with clinical Ebola Virus Disease can tolerate. Researchers will assess the amount, frequency and number of treatment days while monitoring safety signals and the effects of the underlying disease.
NanoViricides said enrolment is proceeding cautiously because NV-387 is a new chemical entity. The company said enrolment may accelerate as clinical experience increases, although Phase IIA requires only a small number of patients.
Phase IIA is not designed to establish efficacy statistically. Instead, NanoViricides described it as a decision point for determining whether to proceed to Phase IIB. If a suitable regimen is identified, the company intends to use it in an expanded, randomized and controlled trial to assess NV-387 Oral Gummies in Ebola patients.
#How the company describes NV-387
NanoViricides says NV-387 is designed to reduce viral load by acting on a host-side feature called heparan sulfate proteoglycan, or HSPG. The company says over 90-95% of human pathogenic viruses require HSPG to infect cells. Whether the medicine is safe and effective in Ebola patients remains subject to the clinical trial results.
The product is formulated as an oral gummy that dissolves in the mouth without requiring water or a conventional swallowing action, according to the company. NanoViricides says this could simplify administration for seriously ill patients with swallowing difficulties and in remote locations, if the product is found to be effective.
The company also cautioned that a reduction in viral load does not necessarily mean immediate recovery of bodily functions. It said organs may take longer to recover after viral levels become undetectable, and permanent damage, including kidney damage, may remain.
#DRC outbreak continues to worsen
Data released by the DRC government on October 2, 2026, showed 4,018 deaths and 8,300 confirmed cases. NanoViricides said the crude case fatality rate remained at about 48%, while the infection-to-fatality rate remained at about 67%.
The company said earlier outbreak locations, including Ituri, may have stabilised, but cases have been increasing in Nord Kivu, which accounted for 40% of confirmed national cases. It also cited limited treatment capacity in the province, with 29 beds in treatment centres and about 20 beds in transit facilities for suspected cases awaiting diagnosis.
NanoViricides further reported 6 new cases in an eastern part of the DRC controlled by rebel groups. It said the movement of thousands of refugees from a camp where more than 30 people had died from Ebola increased the risk of further transmission.
The outbreak was declared a Public Health Emergency of International Concern by the World Health Organization on May 17, 2026. NanoViricides said there is no approved treatment or vaccine for the new Bundibugyo variant associated with the current outbreak.
#Other Ebola approaches and development risks
Several other efforts are under way, according to the company. An obeldesivir trial that began in July, 2026, is studying post-exposure prophylaxis in people who have been in contact with a case but do not have symptoms. A separate PARTNERS trial is evaluating infusions of the antibody cocktail MBP134, Remdesivir, and the two treatments together.
NanoViricides said infusion-based treatments can be difficult to deploy and expand in resource-limited settings. It contrasted those approaches with the oral delivery of NV-387, while stressing that the product's value in the outbreak depends on it being effective in the clinical trial.
The company said its broader development programme includes NV-387 for RSV, COVID, Long COVID, Influenza, other respiratory viral infections and MPOX/Smallpox infections. Its other advanced candidate is NV-HHV-1 for Shingles. NanoViricides said it cannot project an exact date for filing an IND for any of its drugs because it depends on external collaborators and consultants.
NanoViricides also stated that pharmaceutical development is lengthy and requires substantial capital. It said there can be no assurance that its candidates will demonstrate sufficient effectiveness and safety for human clinical development, that laboratory findings will lead to successful clinical trials or that a successful pharmaceutical product will result. The company identified additional risks involving development, regulatory approvals, commercialisation and market acceptance, and said actual events could differ materially from its forward-looking statements.
#Company background
NanoViricides is a clinical-stage company developing special-purpose nanomaterials for antiviral therapy. It says its technology-related business model is based on licensing arrangements with TheraCour Pharma, Inc., including broad, exclusive, sub-licensable field licences for drugs developed in several licensed fields. NanoViricides shares trade on NYSE American under the ticker NNVC.
#Key Takeaways
- NanoViricides said Phase IIA enrolment for its NV-387 Oral Gummies Ebola trial began on or about September 23, 2026.
- The initial phase is focused on identifying a tolerable dosage regimen and is not designed to measure efficacy statistically.
- A planned Phase IIB study would be randomized and controlled and would evaluate NV-387 in Ebola patients if the earlier stage supports proceeding.
- DRC government data released on October 2, 2026, recorded 4,018 deaths and 8,300 confirmed cases.
- NanoViricides said the drug's effectiveness and safety remain unproven, and that its development programme carries clinical, regulatory and commercial risks.
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