NanoViricides, Inc. (NYSE American: NNVC) announced that the Pillar Committee in Charge in the Democratic Republic of Congo 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 targets host-cell features required by viruses. According to the company, NV-387 is the only orally administered Ebola treatment candidate currently under consideration for clinical testing.
The next steps include 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. Management believes the oral formulation could offer significant advantages in resource-limited outbreak settings, where intravenous treatments can be difficult to deploy and scale. The ability to administer treatment orally could simplify logistics, reduce the need for trained medical personnel, and improve patient compliance in remote areas.
NanoViricides is a clinical-stage company that creates special purpose nanomaterials for antiviral therapy. Its lead drug candidate, NV-387, is a broad-spectrum antiviral being developed for multiple viral infections, including RSV, COVID-19, Long COVID, influenza, and mpox. The company’s technology is based on intellectual property licensed from TheraCour Pharma, Inc. The DRC approval for the Ebola trial builds on prior regulatory progress, as NV-387 Oral Gummies were already authorized for a Phase II mpox trial in the country.
The significance of this announcement lies in the potential for an oral treatment to address the challenges of Ebola outbreaks in Africa. Current standard-of-care treatments, such as intravenous monoclonal antibodies, require cold chain storage and skilled healthcare workers for administration, limiting their reach. An oral gummy formulation could be distributed more easily and taken without medical supervision, potentially increasing access to treatment during outbreaks. The Bundibugyo ebolavirus strain, which has a lower fatality rate than Zaire ebolavirus, still poses a public health threat, and effective oral therapies could help contain future epidemics.
For more information, refer to the full press release at https://nnw.fm/1ewVT. Updates on NanoViricides are available in the company’s newsroom at https://nnw.fm/NNVC.
