NanoViricides, Inc. (NYSE American: NNVC) has announced it has applied to the Democratic Republic of Congo’s (DRC) regulatory agency for approval to launch 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 believes that 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.
NV-387 is NanoViricides’ lead drug candidate, a broad-spectrum antiviral drug that the company plans to develop as a treatment for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections and even Measles. The company’s other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The company is currently focused on advancing NV-387 into Phase II human clinical trials.
NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of various human viral diseases, including Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if initial research is successful.
The company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. Its 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.
The DRC outbreak, caused by the Bundibugyo ebolavirus, has highlighted the urgent need for effective treatments. If approved, the Phase II trial could provide critical data on NV-387’s safety and efficacy in humans. The oral formulation of NV-387 is particularly noteworthy because it could be easier to administer in remote areas where intravenous therapies are challenging. Success in this trial could pave the way for a broad-spectrum antiviral capable of tackling multiple filoviruses, potentially transforming outbreak response in resource-limited settings.
For more information, visit the company’s newsroom at https://ibn.fm/NNVC.
