NanoViricides, Inc. (NYSE American: NNVC) has announced that it is awaiting regulatory approval to initiate a Phase II clinical trial of its NV-387 Oral Gummies for the treatment of Bundibugyo ebolavirus in the Democratic Republic of the Congo (DRC). The company submitted an application to the local regulatory agency and has secured financing to support the study, which aims to address the ongoing Ebola outbreak. Notably, no approved treatment or vaccine currently exists for the Bundibugyo strain.
According to the company, NV-387 is the only orally administered Ebola treatment candidate currently under consideration for clinical testing. Its broad-spectrum antiviral mechanism could offer significant advantages over infusion-based therapies, particularly in resource-limited outbreak settings where intravenous access and cold chain logistics are challenging. NanoViricides stated that sufficient quantities of the drug are already in the DRC to support the planned study, pending regulatory approval.
The development is significant because oral administration can simplify treatment delivery, reduce the burden on healthcare infrastructure, and potentially enable earlier intervention during outbreaks. If approved, NV-387 could fill a critical gap in the therapeutic arsenal against Ebola, especially for the Bundibugyo strain, which has historically received less attention than the Zaire strain.
NanoViricides’ lead drug candidate, NV-387, is a broad-spectrum antiviral being developed for multiple viral infections, including RSV, COVID-19, influenza, and MPOX. The company’s technology is based on nanoviricide(TM) nanomedicines, which are designed to specifically target viruses and deliver antiviral payloads. The company holds exclusive licenses from TheraCour Pharma, Inc. for several antiviral applications.
The announcement comes amid ongoing efforts to combat Ebola outbreaks in Africa. The DRC has experienced multiple Ebola outbreaks since the 1970s, and the current Bundibugyo strain poses unique challenges due to the lack of specific countermeasures. An oral treatment could revolutionize outbreak response by enabling rapid deployment and self-administration, reducing the need for specialized medical staff.
Investors and public health officials will be closely watching the regulatory decision, as successful clinical results could position NanoViricides as a key player in pandemic preparedness. Further information is available in the company’s newsroom at https://ibn.fm/NNVC.
