NanoViricides, Inc. (NYSE American: NNVC) announced it has received National Ethics Committee approval in the Democratic Republic of the Congo (DRC) for a Phase II clinical trial evaluating its NV-387 oral gummies as a treatment for the current Bundibugyo ebolavirus outbreak. The company is now preparing to submit a Clinical Trial Application to the DRC regulatory agency, ACOREP, and noted that the NV-387 drug product is already in the country for an upcoming Phase II Mpox trial, which could enable rapid trial initiation if regulatory approval is received.
The significance of this development lies in the unique position of NV-387 as the only orally administered Ebola treatment currently under consideration for clinical evaluation. In resource-limited outbreak settings, oral administration offers distinct advantages over infusion-based therapies, which require specialized medical infrastructure and trained personnel. The Bundibugyo ebolavirus, one of several ebolaviruses, currently has no approved therapies or vaccines, making the need for effective treatments critical.
NanoViricides believes its broad-spectrum antiviral platform, designed to target host-cell features used by viruses, could provide a treatment option for Bundibugyo and other ebolaviruses. The company’s lead drug candidate, NV-387, is also being developed for other viral infections including RSV, COVID, Long COVID, Influenza, and Mpox/Smallpox. The company’s platform technology is based on TheraCour nanomedicine technology, which NanoViricides holds exclusive licenses for several human viral diseases.
The approval marks an important step forward in addressing the ongoing outbreak in the DRC. The World Health Organization has reported that the Bundibugyo ebolavirus has a lower fatality rate than other ebolaviruses but still poses a significant public health threat. The availability of an oral treatment could greatly improve outbreak response, particularly in remote areas where intravenous treatments are difficult to administer.
For more details, the full press release is available at https://ibn.fm/MuxOe. The latest news and updates relating to NNVC can be found in the company’s newsroom at https://ibn.fm/NNVC.
NanoViricides is a clinical stage company creating special purpose nanomaterials for antiviral therapy. Its novel nanoviricide class of drug candidates is based on intellectual property and technology from TheraCour Pharma, Inc. The company’s business model relies on licensing technology from TheraCour for specific application verticals, established in 2005. As with any drug development efforts, there can be no assurance that pharmaceutical candidates will show sufficient effectiveness and safety for human clinical development.
