NanoViricides, Inc. (NYSE American: NNVC) announced it has applied to the Democratic Republic of Congo's regulatory agency for approval to initiate a Phase II clinical trial evaluating its NV-387 Oral Gummies as a treatment for the current 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 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, which 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 company seeks to address an outbreak that, according to the release, has resulted in more than 930 deaths and nearly 2,400 confirmed cases since May.
The company said it believes NV-387's oral formulation could offer logistical advantages over infusion-based therapies in resource-limited settings and, if successful, could support development of a broad-spectrum treatment for Ebola and other filoviruses. More details are available in the full press release at https://ibn.fm/tmrCX.
NanoViricides is a clinical stage company creating special purpose nanomaterials for antiviral therapy. Its lead drug candidate, NV-387, is being developed for multiple viral infections including RSV, COVID-19, influenza, and Mpox. The company's platform technology is based on the TheraCour nanomedicine technology, which it licenses from TheraCour Pharma, Inc.
If approved, this trial could represent a significant step in addressing the Ebola outbreak in the DRC, offering a potentially more accessible treatment option. The company's focus on host-side mechanisms may also provide a path to broad-spectrum antiviral treatments, which are critical for pandemic preparedness.
