NanoViricides, Inc. (NYSE American: NNVC) 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 preparing to submit a Clinical Trial Application to the DRC regulatory agency, ACOREP, and noted that NV-387 drug product is already in the country for an upcoming Phase II Mpox trial, enabling rapid trial initiation if regulatory approval is received.
NanoViricides said NV-387 is the only orally administered Ebola treatment currently under consideration for clinical evaluation, offering potential advantages over infusion-based therapies in resource-limited outbreak settings. The company 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 that currently have no approved therapies or vaccines.
The approval marks a significant milestone for NanoViricides as it advances its lead drug candidate NV-387 into human clinical trials for Ebola. The company's nanoviricide technology aims to create special purpose nanomaterials that mimic host cell receptors, binding to viruses and neutralizing them. This approach could potentially address multiple viral diseases with a single platform.
According to the press release, NV-387 is also being developed for other viral infections including respiratory syncytial virus (RSV), COVID-19, influenza, Mpox, and measles. The company has obtained broad, exclusive licenses from TheraCour Pharma for several viral disease applications.
The DRC is currently experiencing an outbreak of the Bundibugyo ebolavirus, a strain for which no approved vaccines or treatments exist. The availability of an oral treatment could significantly improve outbreak response in remote areas where intravenous therapies are difficult to administer.
For more information, see the full press release at https://ibn.fm/MuxOe and the company's newsroom at https://ibn.fm/NNVC.
