NanoViricides, Inc. (NYSE American: NNVC) announced it has received National Ethics Committee approval in the Democratic Republic of the Congo 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. This approval marks a significant step forward in addressing the ongoing outbreak, which has raised concerns due to the lack of specific treatments.
The company’s lead drug candidate, NV-387, is a broad-spectrum antiviral drug being developed for multiple viral infections, including RSV, COVID-19, influenza, and Mpox. The oral formulation could be particularly advantageous in the DRC, where infrastructure for intravenous treatments is limited. The ability to administer the drug orally may facilitate wider distribution and adherence, potentially reducing the burden on healthcare systems during outbreaks.
NanoViricides holds a worldwide exclusive perpetual license to its nanoviricide technology for several viral diseases, including Ebola and Marburg viruses. The company’s platform is designed to mimic host cell receptors, allowing the nanoviricide particles to bind to viruses and neutralize them. This mechanism may provide efficacy against multiple strains, including Bundibugyo, for which no approved vaccine or therapy exists.
The upcoming Phase II trial will assess the safety and efficacy of NV-387 in patients infected with Bundibugyo ebolavirus. The company has already positioned drug product in the DRC for its Mpox trial, which could expedite the start of the Ebola study if regulatory clearance is granted. This strategic preparation underscores NanoViricides’ commitment to addressing urgent global health threats.
For more information, see the full press release at https://ibn.fm/MuxOe and follow updates at https://ibn.fm/NNVC.
