Connecticut-based NanoViricides, Inc. (NYSE American: NNVC) has applied to the Democratic Republic of Congo's regulatory agency, ACOREP, for approval to begin a Phase II clinical trial of NV-387 Oral Gummies as a treatment for the Bundibugyo strain of Ebolavirus currently circulating in the country. The company announced the application as the death toll from the outbreak surpassed 930 within roughly two months of its declaration. The study targets Bundibugyo ebolavirus, a species for which no approved therapies currently exist, unlike Zaire ebolavirus, where monoclonal antibody treatments are available.
The application seeks authorization to begin a Phase II study and does not include clinical efficacy or safety data. NanoViricides said drug supplies are already in the DRC following shipment for a previously announced mpox study, but has not disclosed the planned trial design, enrollment target or primary endpoint.
The company describes NV-387 as a broad-spectrum antiviral that mimics heparan sulfate proteoglycan, a host-cell surface molecule that a large proportion of viruses — including all known Ebolaviruses — use as an attachment receptor before entering cells via endosomes. Because the target is a conserved host feature rather than a viral protein, NanoViricides argues the virus cannot readily evade the drug through mutation, in contrast to direct-acting antivirals or monoclonal antibodies that target specific viral epitopes. The company has cited unpublished preclinical studies suggesting NV-387 outperformed remdesivir in a lethal viral animal model, although no Ebola-specific preclinical data accompanied the announcement.
Separately from the NanoViricides filing, a WHO-backed trial evaluating remdesivir infusion, the antibody cocktail MBP134 infusion, and a combination of both began during this outbreak, with the first patient dosed with the antibody cocktail on July 2, 2026, according to Reuters. That trial is further along than the NanoViricides program, having already dosed patients, whereas the NV-387 study remains at the pre-approval application stage in DRC.