NanoViricides, Inc. (NYSE American: NNVC) announced it has submitted an application 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 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, 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.
NanoViricides is a clinical stage company that creates special purpose nanomaterials for antiviral therapy. Its lead drug candidate is NV-387, a broad-spectrum antiviral drug planned for development 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.
The company’s 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 for the treatment of various human viral diseases, including HIV/AIDS, Hepatitis B and C, Rabies, Herpes Simplex Virus, Varicella-Zoster Virus, Influenza, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses.
The announcement highlights NanoViricides’ strategic move to leverage its existing clinical infrastructure in the DRC from the Mpox trial to rapidly address the Ebola outbreak. If approved, the trial could provide critical data on NV-387’s efficacy against filoviruses and potentially lead to a more accessible treatment option for Ebola outbreaks in Africa. The oral formulation of NV-387 is particularly noteworthy as it could circumvent the logistical challenges associated with intravenous therapies, such as the need for cold chain storage and trained medical personnel for administration.
For more details, the full press release is available at https://ibn.fm/tmrCX. Additional information about NanoViricides can be found at https://www.nanoviricides.com.
