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 after submitting an application to the local regulatory agency. The company has secured financing to support the study, which is designed to evaluate the oral antiviral in response to the ongoing Ebola outbreak, where no approved treatment or vaccine currently exists for the Bundibugyo strain.
NanoViricides said NV-387 is the only orally administered Ebola treatment candidate currently under consideration for clinical testing to its knowledge and believes its broad-spectrum antiviral mechanism could offer advantages over infusion-based therapies in resource-limited outbreak settings. The company noted sufficient quantities of the drug are already in the DRC to support the planned Ebola study, pending regulatory approval. The announcement underscores the potential importance of this trial, as the Bundibugyo ebolavirus remains a significant public health threat in the region, and the development of an oral treatment could enhance outbreak response capabilities.
According to the press release, NanoViricides' lead drug candidate is NV-387, a broad-spectrum antiviral drug that the company plans to develop for various viral infections, including RSV, COVID-19, Long COVID, Influenza, MPOX/Smallpox, and Measles. The company is currently focused on advancing NV-387 into Phase II human clinical trials. The company's platform technology is based on the TheraCour nanomedicine technology, which they license from TheraCour Pharma, Inc.
The company also highlighted that NV-387 is the only orally administered Ebola treatment candidate under consideration for clinical testing, according to its knowledge. If approved, this trial could mark a significant step in addressing the unmet medical need for oral antiviral therapies in outbreak settings. The company's ability to secure financing and have drug quantities already in the DRC suggests readiness to proceed quickly once regulatory approval is granted.
For more information, the full press release is available at https://ibn.fm/t1kLC. The latest news and updates relating to NNVC can be found in the company's newsroom at https://ibn.fm/NNVC.
