NanoViricides, Inc. (NYSE American: NNVC), a clinical-stage company developing antiviral drugs, has announced that a Phase II clinical trial of its NV-387 Oral Gummies for the treatment of Bundibugyo Ebolavirus and other Ebola viruses is expected to begin soon in the Democratic Republic of Congo (DRC). The company has received regulatory approval from the local agency ACOREP and has appointed Professor Patrick Katoto as principal investigator. Preparatory work, including staff training, is underway, and the NV-387 drug product is already available in the DRC, with first patient dosing anticipated within a few weeks, barring outbreak-related impediments.
NV-387 is an orally administered broad-spectrum antiviral designed to mimic host-side features that viruses require for infection. The company believes that oral delivery could offer significant advantages in resource-limited outbreak settings compared with treatments that require infusions. This is particularly relevant in the DRC, where healthcare infrastructure may be constrained and intravenous administration could be challenging. The oral gummy formulation may also improve patient compliance and ease of administration, potentially accelerating treatment rollout during outbreaks.
The Phase II trial is being conducted with Om Sai Clinical Research Private Limited serving as the contract research organization (CRO). The same CRO is also supporting the company's planned Phase II trial of NV-387 Oral Gummies for the treatment of Mpox in the DRC, indicating a broader strategy to address multiple viral threats in the region.
Ebola virus disease is a severe, often fatal illness in humans, with case fatality rates ranging from 25% to 90% in past outbreaks. The current outbreak in the DRC involves the Bundibugyo strain, which has a lower fatality rate but still poses a significant public health threat. Having an oral antiviral that can be easily distributed and administered could be a critical tool in controlling outbreaks and reducing mortality.
NanoViricides is a clinical-stage company focused on creating special purpose nanomaterials for antiviral therapy. Its lead drug candidate, NV-387, is being developed for a range of viral infections, including RSV, COVID-19, influenza, and Mpox. The company's technology is based on intellectual property licensed from TheraCour Pharma, Inc. The company has obtained broad, exclusive, sub-licensable field licenses for several viral targets, including Ebola and Marburg viruses.
The initiation of this Phase II trial marks a significant step for NanoViricides in advancing its pipeline. If successful, NV-387 could become a valuable addition to the antiviral arsenal against Ebola, particularly in resource-limited settings where oral formulations are preferred. The trial's progress will be closely watched by public health officials and investors alike, as it could have implications for future outbreak response strategies.
For more information on NanoViricides, visit the company's newsroom at https://ibn.fm/NNVC.
