NanoViricides, Inc. (NYSE American: NNVC) announced it is awaiting regulatory approval to begin a Phase II clinical trial of its NV-387 Oral Gummies for the treatment of Bundibugyo ebolavirus in the Democratic Republic of the Congo. The company submitted an application to the local regulatory agency and has secured financing to support the study, which is designed to evaluate the oral antiviral in response to the ongoing Ebola outbreak. According to the company, no approved treatment or vaccine currently exists for the Bundibugyo strain.
NanoViricides stated that NV-387 is the only orally administered Ebola treatment candidate currently under consideration for clinical testing, to its knowledge. The company believes its broad-spectrum antiviral mechanism could offer advantages over infusion-based therapies in resource-limited outbreak settings. The company noted that sufficient quantities of the drug are already in the DRC to support the planned Ebola study, pending regulatory approval.
The announcement comes as the DRC continues to face outbreaks of Ebola virus disease. The Bundibugyo ebolavirus is one of several species of the virus, and the lack of specific treatments highlights the need for novel therapeutic options. NV-387 is designed as an oral gummy formulation, which could simplify administration compared to intravenous therapies often used in outbreak settings.
NanoViricides is a clinical stage company focused on creating special purpose nanomaterials for antiviral therapy. The company's lead drug candidate, NV-387, is being developed for multiple viral infections, including respiratory syncytial virus (RSV), COVID-19, influenza, and others. The company holds a worldwide exclusive perpetual license to TheraCour nanomedicine technology for several antiviral drugs.
The planned Phase II trial would evaluate the safety and efficacy of NV-387 in patients infected with Bundibugyo ebolavirus. If approved, the study could provide valuable data on the drug's potential as a treatment for Ebola. The company's ability to secure financing and have drug supplies ready in the DRC suggests a proactive approach to addressing the outbreak.
Investors can find the latest news and updates relating to NNVC in the company's newsroom at https://ibn.fm/NNVC. The full press release is available at https://ibn.fm/t1kLC.
