NanoViricides Seeks Approval for Phase II Ebola Trial in DRC Amid Ongoing Outbreak

NanoViricides, Inc. (NYSE American: NNVC) announced it has submitted an application to the Democratic Republic of Congo’s regulatory agency for approval to initiate a Phase II clinical trial evaluating its NV-387 Oral Gummies as a treatment for the ongoing Bundibugyo ebolavirus outbreak. The company has retained Om Sai Clinical Research Private Limited as the contract research organization for the study, with drug supplies already in the country. NV-387 is an orally administered broad-spectrum antiviral designed to target host-side mechanisms that viruses rely on to infect cells, potentially reducing the likelihood of viral resistance.

The planned study builds on NanoViricides’ ongoing Phase II Mpox trial in the DRC and comes as the company seeks to address an outbreak that, according to the release, has resulted in more than 930 deaths and nearly 2,400 confirmed cases since May. The company believes NV-387’s oral formulation could offer logistical advantages over infusion-based therapies in resource-limited settings. If successful, the drug could support development of a broad-spectrum treatment for Ebola and other filoviruses.

NanoViricides’ lead drug candidate, NV-387, is also being developed for RSV, COVID-19, Long COVID, influenza, and other respiratory viral infections, as well as Mpox, smallpox, and measles. The company’s platform technology is based on the TheraCour nanomedicine technology, licensed from TheraCour Pharma, Inc. NanoViricides holds a worldwide exclusive perpetual license for several drugs targeting specific mechanisms for the treatment of various human viral diseases, including HIV/AIDS, hepatitis B and C, rabies, herpes simplex, influenza, dengue, Japanese encephalitis, West Nile virus, Ebola/Marburg viruses, and certain coronaviruses.

The company’s business model relies on licensing technology from TheraCour for specific application verticals. NanoViricides has obtained broad, exclusive, sub-licensable field licenses for drugs developed in several licensed fields. The company notes that the path to typical drug development is extremely lengthy and requires substantial capital, and there can be no assurance that any of its pharmaceutical candidates will show sufficient effectiveness and safety for human clinical development.

For more information, visit the company’s newsroom at https://ibn.fm/NNVC and the full press release at https://ibn.fm/tmrCX.