NanoViricides, Inc. (NYSE American: NNVC) announced it has applied to the Democratic Republic of Congo's regulatory agency for approval to initiate 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 positioned 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, potentially reducing 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 believes NV-387's oral formulation could offer logistical advantages over infusion-based therapies in resource-limited settings and, if successful, could support development of a broad-spectrum treatment for Ebola and other filoviruses. For the full press release, visit https://ibn.fm/tmrCX.
NanoViricides is a clinical stage company creating special purpose nanomaterials for antiviral therapy. Its lead drug candidate is NV-387, 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's platform technology is based on the TheraCour nanomedicine technology, licensed from TheraCour Pharma, Inc. For more information about NanoViricides, visit https://www.nanoviricides.com.
The significance of this announcement lies in the urgent need for effective treatments against the current Ebola outbreak in the DRC, which has caused substantial morbidity and mortality. If approved, the Phase II trial could provide critical data on NV-387's efficacy and safety, potentially leading to a new therapeutic option that is easier to administer in low-resource settings compared to existing intravenous therapies. Moreover, a successful trial would underscore the potential of broad-spectrum antivirals targeting host factors, paving the way for treatments against multiple filoviruses.
