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 submitted an application to the local regulatory agency and has secured financing to support the study, which is designed to evaluate the oral antiviral in response to the ongoing Ebola outbreak.
According to the company, NV-387 is the only orally administered Ebola treatment candidate currently under consideration for clinical testing. Its broad-spectrum antiviral mechanism could offer advantages over infusion-based therapies in resource-limited outbreak settings, where intravenous treatments are often difficult to administer. Sufficient quantities of the drug are already in the DRC to support the planned study, pending regulatory approval.
The Bundibugyo ebolavirus strain, for which no approved treatment or vaccine currently exists, has been the focus of recent outbreaks. The company believes that NV-387's unique mechanism of action may provide a much-needed therapeutic option. NanoViricides' platform technology is based on TheraCour nanomedicine technology, licensed from TheraCour Pharma, Inc., and the company holds exclusive licenses for several antiviral indications.
NanoViricides is a clinical stage company focused on creating special purpose nanomaterials for antiviral therapy. Its lead drug candidate, NV-387, is also being developed for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox and Measles. The company's other advanced drug candidate is NV-HHV-1 for treating Shingles.
The company noted that the path to typical 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 in an outbreak setting underscores the importance of this regulatory decision.
For more information, visit the company's newsroom at https://ibn.fm/NNVC and the full press release at https://ibn.fm/t1kLC.
