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.
The significance of this development lies in the urgent need for effective treatments against ebolaviruses, particularly the Bundibugyo strain, which currently has no approved therapies or vaccines. NV-387 is the only orally administered Ebola treatment under consideration for clinical evaluation, offering potential advantages over infusion-based therapies in resource-limited outbreak settings. According to NanoViricides, its broad-spectrum antiviral platform, designed to target host-cell features used by viruses, could provide a treatment option for Bundibugyo and other ebolaviruses.
The approval marks a critical step forward for the company, which is also conducting Phase II trials for NV-387 against Mpox. The ability to leverage existing drug supplies in the DRC could accelerate the timeline for the Ebola trial. NanoViricides believes that NV-387's oral formulation could improve patient access and reduce the burden on healthcare infrastructure during outbreaks.
For more details, the full press release is available at https://ibn.fm/MuxOe.
NanoViricides is a clinical-stage company specializing in nanomaterial-based antiviral therapies. Its lead candidate, NV-387, is being developed for multiple viral infections, including respiratory syncytial virus (RSV), COVID-19, influenza, and Mpox. The company's technology is based on the TheraCour nanomedicine platform, licensed from TheraCour Pharma, Inc.
The company notes that drug development is lengthy and capital-intensive, and there is no assurance that NV-387 will prove safe and effective in clinical trials. However, the ethics approval in the DRC represents a milestone for NanoViricides and potentially for global health efforts to combat emerging viral threats.
Investors can find the latest news and updates regarding NNVC in the company’s newsroom at https://ibn.fm/NNVC.
