NanoViricides, Inc. (NYSE American: NNVC) announced it is awaiting regulatory approval to begin a Phase II clinical trial of its NV-387 Oral Gummies for the treatment of Bundibugyo ebolavirus in the Democratic Republic of the Congo. The company has submitted an application to the local regulatory agency and secured financing to support the study, which is designed to evaluate the oral antiviral in response to the ongoing Ebola outbreak.
The Bundibugyo strain, for which no approved treatment or vaccine currently exists, poses a significant public health challenge. NanoViricides stated that NV-387 is the only orally administered Ebola treatment candidate currently under consideration for clinical testing, to its knowledge. The company believes its broad-spectrum antiviral mechanism could offer advantages over infusion-based therapies in resource-limited outbreak settings.
Sufficient quantities of the drug are already in the DRC to support the planned study, pending regulatory approval. The company's nanoviricide technology, licensed from TheraCour Pharma, Inc., forms the basis for NV-387 and other drug candidates targeting a range of viral diseases, including RSV, COVID-19, influenza, and MPOX.
NanoViricides’ business model relies on licensing technology from TheraCour for specific application verticals. The company holds a worldwide exclusive perpetual license for several drugs targeting human viral diseases such as HIV, hepatitis B and C, rabies, herpes, influenza, dengue, Japanese encephalitis, West Nile virus, Ebola/Marburg viruses, and certain coronaviruses.
The company noted that the path to drug development is lengthy and requires substantial capital, and there can be no assurance that any of its candidates will show sufficient effectiveness and safety for human clinical development. However, the potential for an oral treatment for Ebola could be a game-changer in outbreak management, especially in regions with limited healthcare infrastructure.
For more information, visit the company’s newsroom at https://ibn.fm/NNVC and the full press release at https://ibn.fm/t1kLC.
