NanoViricides, Inc. (NYSE American: NNVC) says a Phase II clinical trial of its oral NV-387 gummies for Ebola is scheduled to begin next week at an Ebola Treatment Center in Ituri province, Democratic Republic of Congo. The company said first patient dosing remains subject to impediments created by the outbreak the study is intended to address.
The planned study will examine NV-387 alongside optimised supportive care in adults with Ebola virus disease caused by Bundibugyo ebolavirus or other orthoebolaviruses. The announcement does not report that dosing has started or that the drug has demonstrated effectiveness against Ebola in humans.
#Planned trial design and oversight
NanoViricides describes the study as an adaptive, multi-centre Phase IIA/IIB trial. The first stage is a single-arm safety and dose run-in. This is intended to be followed by a randomised, controlled, open-label efficacy evaluation with independent blinded-endpoint adjudication.
Prof. Patrick de Marie Chimusa Katoto is the principal investigator. Om Sai Clinical Research Private Limited, India, is serving as the contract research organisation for the trial. The study is registered under identification number PACTR202608748555077 in the Pan African Clinical Trials Registry.
The company says travel restrictions and shortages of personal protective equipment and diagnostic kits have already affected preparations. It expects the difficult operating conditions surrounding the outbreak to continue causing delays.
#How the study differs from current treatment research
NanoViricides says approximately 300 patients have been enrolled in the PARTNERS clinical trial, which started as of July 2, 2026. That study has four groups: an infusion of the monoclonal antibody cocktail MBP134; an infusion of Remdesivir; infusions of both MBP134 and Remdesivir; and a control group receiving local standard of care.
According to the company, the PARTNERS trial will require over 1,000 patients to be treated and may not produce results for several months. NanoViricides says infusion-based treatment presents logistical challenges in resource-poor areas and creates risks for healthcare workers through needle-sticks, patient handling and possible blood exposure.
The company describes NV-387 as an oral treatment that dissolves in the mouth and does not require water or a swallowing effort. It says the drug was compared with intravenously administered Remdesivir in animal studies involving a lethal coronavirus infection model, where NV-387 extended survival more effectively. That finding comes from animal research involving coronavirus, not from a human Ebola trial.
NanoViricides says it believes the preclinical results provide a basis for expecting activity against Ebola, but company President Anil R. Diwan said clinical-trial data will determine whether NV-387 is effective. The company also states that there can be no assurance that its drug candidates will show sufficient safety or effectiveness for human clinical development or become successful pharmaceutical products.
#Reported scale of the DRC outbreak
Figures cited by NanoViricides from a World Health Organization daily report show that, as of September 10, 2026, the Democratic Republic of Congo had recorded 7,022 confirmed cases, 3,398 confirmed deaths and 1,671 confirmed recoveries. The company reports a crude fatality rate of about 48%.
NanoViricides says the outbreak is present in at least six provinces in the DRC and is threatening South Sudan. It also reports that at least 43 healthcare workers have died from Ebola and at least 160 have contracted the disease.
The company says there is no approved treatment or vaccine for the new Bundibugyo ebolavirus variant associated with the current outbreak. It also notes that existing approved Ebola therapies are specific to the Zaire strain and would require further clinical trials to establish usefulness against the current virus.
#Development and regulatory limitations
NanoViricides says its Ebola programme remains subject to the normal uncertainties of pharmaceutical development. The company cannot project an exact date for filing an Investigational New Drug application for any of its medicines because it depends on external collaborators and consultants.
The company further states that references to safety and effectiveness in its announcement describe research findings, including clinical trials, and do not represent an evaluation by the US Food and Drug Administration. Whether NV-387 can provide a clinical benefit against Ebola will depend on the results of the planned study.
#Key Takeaways
- NanoViricides says its Phase II trial of oral NV-387 gummies for Ebola is scheduled to start next week in Ituri province, subject to outbreak-related impediments.
- The study will evaluate NV-387 plus optimised supportive care in adults with Bundibugyo or other orthoebolavirus disease.
- The company reports 7,022 confirmed cases, 3,398 confirmed deaths and 1,671 confirmed recoveries in the DRC as of September 10, 2026, with a crude fatality rate of about 48%.
- Approximately 300 patients have been enrolled in the separate PARTNERS trial of MBP134, Remdesivir, their combination and local standard of care.
- NanoViricides says clinical data, rather than preclinical findings, will determine whether NV-387 is effective against Ebola.
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