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. To view the full press release, visit https://ibn.fm/MuxOe.
This approval marks a significant step forward for NanoViricides, a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The company's lead drug candidate is NV-387, a broad-spectrum antiviral drug that it plans to develop as a treatment for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections and Measles. The company is currently focused on advancing NV-387 into Phase II human clinical trials.
The Bundibugyo ebolavirus is one of several ebolaviruses that currently have no approved therapies or vaccines. The ability to provide an oral treatment could significantly impact outbreak control, particularly in remote areas where intravenous infusions are difficult to administer. NanoViricides' platform technology and programs are based on the TheraCour nanomedicine technology, which the company licenses for several drugs with specific targeting mechanisms for a range of human viral diseases, including HIV/AIDS, Hepatitis B and C, Rabies, Herpes, Influenza, Dengue, Japanese Encephalitis, West Nile, Ebola/Marburg, and certain Coronaviruses.
The company also noted that its NV-387 drug product is already in the DRC for an upcoming Phase II Mpox trial, which could expedite the start of the Ebola trial. The company believes that since remdesivir is already US FDA approved, its drug candidate encapsulating remdesivir is likely to be an approvable drug if safety is comparable. However, as with any drug development efforts, there can be no assurance at this time that any of the company's pharmaceutical candidates will show sufficient effectiveness and safety for human clinical development.
For more information about NanoViricides, visit the company's newsroom at https://ibn.fm/NNVC.
