NanoViricides, Inc. (NYSE American: NNVC) announced it has submitted an application to the Democratic Republic of Congo’s regulatory agency seeking approval to initiate a Phase II clinical trial of its NV-387 Oral Gummies for the ongoing Bundibugyo ebolavirus outbreak. The company has retained Om Sai Clinical Research Private Limited as the contract research organization for the study, with drug supplies already positioned in the DRC. NV-387 is an orally administered broad-spectrum antiviral designed to target host-side mechanisms that viruses rely on to infect cells, a strategy the company believes may reduce the likelihood of viral resistance.
The planned study builds on NanoViricides’ ongoing Phase II Mpox trial in the DRC and comes as the region grapples with a severe outbreak that has resulted in more than 930 deaths and nearly 2,400 confirmed cases since May, according to the release. The company emphasized that NV-387’s oral formulation could offer significant logistical advantages over infusion-based therapies in resource-limited settings. If successful, the treatment could support the development of a broad-spectrum therapy for Ebola and other filoviruses.
NanoViricides stated that the application marks a critical step in addressing the urgent need for effective treatments against the Bundibugyo ebolavirus, which is a distinct species from the more common Zaire ebolavirus. The company’s broader pipeline includes NV-387 as a lead drug candidate for respiratory viral infections, including RSV, COVID-19, and influenza, as well as MPOX and smallpox. The company’s platform technology is based on TheraCour nanomedicine, licensed from TheraCour Pharma, Inc., which also underpins other candidates like NV-HHV-1 for shingles.
The announcement highlights the potential of oral antivirals to improve outbreak response in regions with limited healthcare infrastructure. The full press release is available at https://ibn.fm/tmrCX. For more information about NanoViricides, visit www.nanoviricides.com.
