NanoViricides, Inc. (NYSE American: NNVC) announced it has submitted an application to the Democratic Republic of Congo’s regulatory agency seeking approval to initiate a Phase II clinical trial for its NV-387 Oral Gummies as a treatment for the current Bundibugyo ebolavirus outbreak. The company has retained Om Sai Clinical Research Private Limited as the contract research organization for the study, with drug supplies already in the DRC.
NV-387 is an orally administered broad-spectrum antiviral designed to target host-side mechanisms that viruses rely on to infect cells. The company believes this approach may reduce the likelihood of viral resistance. The planned study builds on NanoViricides’ ongoing Phase II Mpox trial in the DRC. According to the press release, the current Ebola outbreak has resulted in more than 930 deaths and nearly 2,400 confirmed cases since May.
The company emphasized that NV-387’s oral formulation could offer logistical advantages over infusion-based therapies in resource-limited settings. If successful, the treatment could support development of a broad-spectrum therapy for Ebola and other filoviruses. For more details, the full press release is available at https://ibn.fm/tmrCX.
NanoViricides is a clinical-stage company focused on creating special purpose nanomaterials for antiviral therapy. Its lead drug candidate, NV-387, is being developed for multiple viral infections, including RSV, COVID-19, influenza, and Mpox. The company’s platform technology is based on the TheraCour nanomedicine technology. Investors can find the latest news and updates regarding NNVC at https://ibn.fm/NNVC.
The announcement comes as the DRC grapples with a significant public health emergency. The availability of an oral treatment could be critical in areas where intravenous therapies are difficult to administer. The company believes that targeting host mechanisms reduces the potential for viral resistance, a common challenge with antiviral drugs.
NanoViricides holds exclusive licenses to develop drugs against a range of viruses, including HIV, hepatitis B and C, rabies, herpes, influenza, dengue, and Ebola. The company’s business model relies on licensing technology from TheraCour Pharma Inc. for specific applications. As with any drug development, there is no assurance that NV-387 will prove effective or safe in human trials.
The Phase II trial in the DRC represents a significant step for the company and could provide a new tool in the fight against Ebola. The outbreak, which began in May, has already caused substantial morbidity and mortality. With drug supplies already in the country, the trial could commence quickly upon regulatory approval.
