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 approval marks a significant step for NanoViricides as it seeks to address the ongoing outbreak in the DRC. According to the company, NV-387 has already been manufactured and positioned in the country for the Mpox trial, which could accelerate the Ebola study start. The oral formulation may reduce the burden on healthcare infrastructure compared to intravenous treatments, which require trained personnel and sterile equipment.
NanoViricides' technology is based on nanoviricide(TM) nanomaterials designed to mimic host cell receptors, binding to viruses and neutralizing them. The platform is intended to be broad-spectrum, targeting multiple viruses by blocking their entry into cells. The company holds licenses from TheraCour Pharma, Inc. for several antiviral applications, including Ebola, HIV, influenza, and coronaviruses.
The Phase II trial will assess the safety and efficacy of NV-387 in patients infected with Bundibugyo ebolavirus. This strain has caused outbreaks in the past, and there are currently no approved vaccines or specific treatments. The World Health Organization has declared the outbreak a public health emergency, underscoring the need for therapeutic options.
For more details, the full press release is available at https://ibn.fm/MuxOe.
Investors can find the latest news and updates relating to NNVC in the company’s newsroom at https://ibn.fm/NNVC.
