NanoViricides, Inc. (NYSE American: NNVC) announced that the Pillar Committee in Charge in the Democratic Republic of Congo (DRC) has approved the company’s proposal to conduct a Phase II clinical trial evaluating NV-387 Oral Gummies as a treatment for the current Bundibugyo ebolavirus outbreak. This approval marks a significant step forward for the company’s broad-spectrum antiviral candidate, which is designed to target host-cell features required by viruses and is, to its knowledge, the only orally administered Ebola treatment candidate currently under consideration for clinical testing.
The next steps involve obtaining approvals from the DRC National Ethics Committee and regulatory agency ACOREP before initiating the study. NanoViricides noted that NV-387 Oral Gummies have already received authorization in the DRC for a Phase II mpox trial and are ready for shipment. The company believes that the oral formulation could offer significant advantages in resource-limited outbreak settings, where intravenous treatments can be difficult to deploy and scale.
NV-387 is the company’s lead drug candidate, a broad-spectrum antiviral 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 Measles. The company’s platform technology is based on the TheraCour® nanomedicine technology, which it licenses from TheraCour Pharma, Inc. 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, Influenza, Dengue, Ebola/Marburg, and certain Coronaviruses.
The approval of the Phase II Ebola trial is particularly important given the ongoing outbreak of Bundibugyo ebolavirus in the DRC. Oral administration of NV-387 could simplify logistics and improve patient compliance compared to intravenous therapies, which require cold chain storage and trained medical personnel for administration. This could enable faster and broader deployment of treatment in remote areas, potentially reducing mortality and curbing the spread of the virus.
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NanoViricides is a clinical stage company focused on creating special purpose nanomaterials for antiviral therapy. The company’s novel nanoviricide class of drug candidates and technology are based on intellectual property, technology, and proprietary know-how of TheraCour Pharma, Inc. The company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections.
As with any drug development efforts, there can be no assurance at this time that any of the company’s pharmaceutical candidates will show sufficient effectiveness and safety for human clinical development or result in a successful pharmaceutical product.
