NanoViricides, Inc. (NYSE American: NNVC) has submitted an application to the Democratic Republic of Congo’s (DRC) regulatory agency seeking approval to initiate a Phase II clinical trial of its NV-387 Oral Gummies for the treatment of the current Bundibugyo ebolavirus outbreak. The company announced that it 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 that 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.
NanoViricides is a clinical stage company creating special purpose nanomaterials for antiviral therapy. Its lead drug candidate NV-387 is being developed as a treatment for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections and Measles. The company’s platform technology and programs are based on the TheraCour nanomedicine technology of TheraCour Pharma, Inc., which NanoViricides licenses from TheraCour. The company holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms for the treatment of various human viral diseases, including HIV/AIDS, Hepatitis B and C, Rabies, Herpes Simplex Virus, Influenza, Dengue viruses, Ebola/Marburg viruses, and certain Coronaviruses.
The company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005. NanoViricides has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The company notes that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital.
For more information, visit the company’s newsroom at https://ibn.fm/NNVC and the full press release at https://ibn.fm/tmrCX.
