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 (DRC). 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.
The Bundibugyo strain of ebolavirus has no approved treatment or vaccine, highlighting the potential significance of NV-387. 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.
NanoViricides noted that sufficient quantities of the drug are already in the DRC to support the planned Ebola study, pending regulatory approval. The company's lead drug candidate, NV-387, is also being developed as a treatment for RSV, COVID-19, influenza, and other viral infections. The company is focused on advancing NV-387 into Phase II human clinical trials.
According to the press release, NanoViricides' platform technology is based on TheraCour nanomedicine technology, licensed from TheraCour Pharma, Inc. The company holds exclusive licenses for several antiviral drugs targeting HIV/AIDS, hepatitis B and C, rabies, herpes, influenza, dengue, Japanese encephalitis, West Nile virus, Ebola/Marburg viruses, and certain coronaviruses.
The announcement comes as the DRC continues to face Ebola outbreaks, and the potential for an oral treatment could significantly impact outbreak control efforts. The company's press release can be viewed at https://ibn.fm/t1kLC. For more information on NanoViricides, visit their newsroom at https://ibn.fm/NNVC.
NanoViricides is a clinical stage company creating special purpose nanomaterials for antiviral therapy. The company's novel nanoviricide class of drug candidates is based on intellectual property and technology from TheraCour Pharma, Inc. The company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections.
As with any drug development efforts, there can be no assurance at this time that NV-387 will show sufficient effectiveness and safety for human clinical development. However, the potential for an oral treatment for Ebola could address a significant unmet medical need, particularly in regions where intravenous therapies are challenging to administer.
