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. For more details, see the full press release here.
NV-387 is the company's lead drug candidate, a broad-spectrum antiviral being developed for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox and Measles. The company is also developing drugs against several other viral diseases including oral and genital Herpes, viral eye diseases, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus. NanoViricides’ platform technology is based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license for several drugs targeting specific mechanisms for human viral diseases.
The approval marks a significant step for NanoViricides in addressing the Bundibugyo ebolavirus outbreak, which has no approved treatments or vaccines. The oral formulation could ease administration in remote areas where intravenous therapies are challenging. The company's ability to initiate the trial quickly, with drug product already in the DRC, may accelerate the evaluation of NV-387's efficacy. This development underscores the potential of broad-spectrum antivirals in pandemic preparedness and outbreak response.
