NanoViricides, Inc. (NYSE American: NNVC) announced it has applied to the Democratic Republic of Congo’s regulatory agency for approval to launch a Phase II clinical trial evaluating its NV-387 Oral Gummies as a treatment for the current Bundibugyo ebolavirus outbreak. The company has retained Om Sai Clinical Research Private Limited as the contract research organization for the study, with drug supplies already in the DRC.
NV-387 is an orally administered broad-spectrum antiviral designed to target host-side mechanisms that viruses rely on to infect cells, which the company believes may reduce the likelihood of viral resistance. The planned study builds on NanoViricides’ ongoing Phase II Mpox trial in the DRC and comes as the company seeks to address an outbreak that, according to the release, has resulted in more than 930 deaths and nearly 2,400 confirmed cases since May.
The company said it believes NV-387’s oral formulation could offer logistical advantages over infusion-based therapies in resource-limited settings. If successful, the trial could support development of a broad-spectrum treatment for Ebola and other filoviruses. This is particularly important given the high mortality rate and the challenges of delivering intravenous treatments in remote areas of the DRC.
NanoViricides is a clinical stage company creating special purpose nanomaterials for antiviral therapy. Its lead drug candidate NV-387 is being developed for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox and Measles. The company’s platform technology and programs are based on the TheraCour nanomedicine technology, which NanoViricides holds a worldwide exclusive perpetual license for several drugs targeting specific human viral diseases, including Ebola/Marburg viruses.
The outbreak, declared a public health emergency, underscores the urgent need for effective treatments. The DRC has faced recurrent Ebola outbreaks, and the current Bundibugyo strain adds complexity as it differs from the Zaire strain targeted by existing vaccines and therapies. An oral treatment like NV-387 could be easier to distribute and administer, potentially improving patient outcomes in outbreak settings.
For more details, the full press release is available at https://ibn.fm/tmrCX. Latest news and updates relating to NNVC are available in the company’s newsroom at https://ibn.fm/NNVC.
NanoViricides’ efforts come at a critical time as the DRC battles its latest Ebola outbreak, which has already claimed hundreds of lives. The success of this trial could pave the way for a new class of oral antivirals that are easier to deploy in low-resource settings, potentially transforming the response to future filovirus outbreaks.
