NanoViricides, Inc. (NYSE American: NNVC) announced it has received National Ethics Committee approval in the Democratic Republic of the Congo (DRC) for a Phase II clinical trial evaluating its NV-387 oral gummies as a treatment for the current Bundibugyo ebolavirus outbreak. The company is preparing to submit a Clinical Trial Application to the DRC regulatory agency, ACOREP, and noted that NV-387 drug product is already in the country for an upcoming Phase II Mpox trial, enabling rapid trial initiation if regulatory approval is received.
NanoViricides said NV-387 is the only orally administered Ebola treatment currently under consideration for clinical evaluation, offering potential advantages over infusion-based therapies in resource-limited outbreak settings. The company believes its broad-spectrum antiviral platform, designed to target host-cell features used by viruses, could provide a treatment option for Bundibugyo and other ebolaviruses that currently have no approved therapies or vaccines. For more details, see the full press release at https://ibn.fm/MuxOe.
The approval marks a significant milestone for NanoViricides as it advances its lead drug candidate NV-387 into human trials for Ebola, a disease with high mortality rates and limited treatment options. The oral formulation could be particularly impactful in the DRC and other regions where intravenous therapies are challenging to administer due to lack of infrastructure or trained personnel. The company's broad-spectrum antiviral platform, which targets host-cell features rather than specific viral proteins, may also prove effective against other emerging viral threats.
NanoViricides is a clinical stage company specializing in nanomaterials for antiviral therapy. Its nanoviricide technology is based on intellectual property and proprietary know-how from TheraCour Pharma, Inc., under a Memorandum of Understanding for drug development against all antiviral infections. The company holds exclusive licenses for several drugs targeting specific mechanisms for human viral diseases including HIV/AIDS, Hepatitis B and C, Rabies, Herpes, Influenza, Dengue, Japanese Encephalitis, West Nile, Ebola/Marburg, and certain Coronaviruses.
The company's lead drug candidate NV-387 is being developed as a treatment for RSV, COVID-19, Long COVID, Influenza, and other respiratory viral infections, as well as Mpox/Smallpox and Measles. Another advanced candidate, NV-HHV-1, targets Shingles. NanoViricides is currently focused on advancing NV-387 into Phase II human clinical trials. The company notes that drug development is lengthy and capital-intensive, and there can be no assurance that any of its pharmaceutical candidates will demonstrate sufficient effectiveness and safety for clinical development or commercial approval.
For the latest news and updates on NanoViricides, visit the company's newsroom at https://ibn.fm/NNVC.
