NanoViricides, Inc. (NYSE American: NNVC) announced it has received regulatory approval from ACOREP, the local regulatory agency in the Democratic Republic of Congo (DRC), to initiate a Phase II clinical trial of NV-387 Oral Gummies for the treatment of the current Bundibugyo ebolavirus outbreak and other Ebola viruses. The company has engaged Om Sai Clinical Research Private Limited as the contract research organization, with initial trial preparations already underway to expedite first patient dosing. Sufficient quantities of the oral gummies are already in the DRC to commence the trial.
NV-387 is an investigational broad-spectrum antiviral designed to mimic host-side features required by viruses for infection. The oral formulation could offer significant advantages in resource-limited outbreak settings compared with treatments requiring intravenous infusion, which are often impractical in remote areas. The company cited World Health Organization data showing 4,141 confirmed cases and 1,889 confirmed deaths from the current Bundibugyo ebolavirus outbreak in the DRC as of Aug. 6, 2026.
The approval marks a critical step in addressing an ongoing public health emergency. The Ebola virus has historically caused high mortality rates, and current treatment options, such as monoclonal antibodies and antivirals like remdesivir, require intravenous administration, limiting their use in areas with weak healthcare infrastructure. An oral therapy could be administered more easily, potentially improving patient outcomes and aiding outbreak control.
NanoViricides' lead drug candidate, NV-387, is being developed for multiple viral infections, including respiratory viruses, MPOX, and now Ebola. The company's nanoviricide technology, based on TheraCour Pharma's nanomedicine platform, aims to create broad-spectrum antivirals that mimic host cell receptors, tricking viruses into binding to the nanoviricide instead of the cell. This approach could potentially reduce the likelihood of viral resistance, a significant concern with existing treatments.
The initiation of the Phase II trial in the DRC is particularly notable as it represents a shift toward developing treatments tailored to outbreak settings. The DRC has experienced multiple Ebola outbreaks, and the current one, caused by the Bundibugyo strain, has proven challenging to contain. The availability of an oral drug could allow for easier distribution and administration in community settings, reducing the burden on already strained healthcare systems.
However, the company cautions that drug development is lengthy and capital-intensive, and there is no assurance that NV-387 will demonstrate sufficient efficacy and safety in human trials. Nevertheless, the approval to conduct the trial in an active outbreak zone underscores the urgent need for innovative therapies. If successful, NV-387 could become a valuable tool in the global response to Ebola and other viral hemorrhagic fevers.
The announcement also highlights the growing role of oral formulations in antiviral therapy. With the success of oral antivirals for COVID-19, such as Paxlovid, the development of oral treatments for other viral diseases is a logical progression. NanoViricides' focus on broad-spectrum antivirals could provide a cost-effective and scalable solution to future outbreaks, reducing reliance on complex infusion therapies.
For more information on the press release, visit https://ibn.fm/2Pqu0. For the latest news on NanoViricides, see https://ibn.fm/NNVC.
