NanoViricides, Inc. (NYSE American: NNVC) announced it has received National Ethics Committee approval in the Democratic Republic of the Congo (DRC) for a Phase II clinical trial evaluating its NV-387 oral gummies as a treatment for the current Bundibugyo ebolavirus outbreak. The company is preparing to submit a Clinical Trial Application to the DRC regulatory agency, ACOREP, and noted that NV-387 drug product is already in the country for an upcoming Phase II Mpox trial, enabling rapid trial initiation if regulatory approval is received.
NanoViricides said NV-387 is the only orally administered Ebola treatment currently under consideration for clinical evaluation, offering potential advantages over infusion-based therapies in resource-limited outbreak settings. The company believes its broad-spectrum antiviral platform, designed to target host-cell features used by viruses, could provide a treatment option for Bundibugyo and other ebolaviruses that currently have no approved therapies or vaccines. The full press release is available at https://ibn.fm/MuxOe.
The approval marks a significant step for NanoViricides as it advances its lead drug candidate, NV-387, which is also being developed for respiratory syncytial virus (RSV), COVID-19, influenza, and other viral infections. The company's nanoviricide technology is designed to create special purpose nanomaterials for antiviral therapy, with a platform that targets host-cell features common to multiple viruses, potentially offering broad-spectrum activity. According to the company, NV-387 drug product is already positioned in the DRC for an upcoming Phase II Mpox trial, which could accelerate the Ebola trial timeline if regulatory approval is granted.
NanoViricides' business model relies on licensing technology from TheraCour Pharma Inc., and the company holds exclusive, sub-licensable field licenses for specific viruses. The company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The latest news and updates relating to NNVC are available in the company's newsroom at https://ibn.fm/NNVC.
The Phase II trial in the DRC addresses a critical unmet need, as the Bundibugyo ebolavirus currently has no approved therapies or vaccines. If successful, NV-387 could become the first oral treatment for Ebola, offering logistical advantages over intravenous therapies in remote and resource-limited settings. The company emphasizes that its broad-spectrum antiviral platform could also be effective against other ebolaviruses, potentially providing a treatment option for future outbreaks.
NanoViricides is also developing drugs against a range of viral diseases, including oral and genital herpes, viral eye diseases, influenza, HIV, Hepatitis C, rabies, dengue fever, and others. However, the company cautions that drug development is lengthy and capital-intensive, and there is no assurance that any of its candidates will demonstrate sufficient effectiveness and safety for clinical development. For more information, visit the company's website at http://www.nanoviricides.com.
