NanoViricides, Inc. (NYSE American: NNVC) is awaiting regulatory approval to commence 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. Currently, no approved treatment or vaccine exists for the Bundibugyo strain.
NV-387 is the only orally administered Ebola treatment candidate under consideration for clinical testing, according to NanoViricides. 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 trial's potential importance lies in addressing a critical gap in Ebola response. The Bundibugyo strain has caused outbreaks with high mortality rates, and the lack of a specific treatment underscores the need for novel therapies. An oral formulation like NV-387 could simplify administration, reduce the need for trained medical personnel, and improve patient compliance in remote areas.
NanoViricides' platform technology is based on the TheraCour nanomedicine technology, which the company licenses from TheraCour Pharma, Inc. The company holds exclusive licenses for several antiviral drugs, including those targeting Ebola/Marburg viruses. The NV-387 drug candidate has shown broad-spectrum activity in preclinical studies against various viruses, including RSV, COVID-19, and influenza.
The clinical development path for NV-387 is part of NanoViricides' broader strategy to advance its nanoviricide class of drug candidates. The company's lead candidate is NV-387, which it plans to develop for respiratory viral infections and other indications. The company also has advanced drug candidates for shingles and COVID-19.
For more information, visit the company's newsroom at https://ibn.fm/NNVC or see the full press release at https://ibn.fm/t1kLC.
