NanoViricides, Inc. (NYSE American: NNVC) announced that a Phase II clinical trial of its antiviral candidate NV-387 for the treatment of MPox is expected to begin soon in the Democratic Republic of Congo, with site preparation and staff training scheduled for early April 2026. The study, already approved by the DRC regulatory agency, will evaluate the safety and effectiveness of NV-387 against Clade I MPox, as the company advances regulatory development and seeks Orphan Drug Designation from the U.S. FDA.
The initiation of this trial marks a significant step in addressing the ongoing MPox outbreak, particularly in Africa where Clade I has been associated with higher mortality rates. NV-387 is a broad-spectrum antiviral drug candidate that the company plans to develop for multiple viral infections, including respiratory syncytial virus (RSV), COVID-19, influenza, and MPox. The trial's focus on Clade I MPox in the DRC underscores the urgent need for effective treatments in regions heavily affected by the virus.
NanoViricides' technology platform is based on novel nanomaterial-based drug candidates designed to target viruses directly. The company has a Memorandum of Understanding with TheraCour Pharma, Inc. for the development of drugs based on these technologies. The company's lead drug candidate, NV-387, is a broad-spectrum antiviral that the company believes could be effective against a range of viral diseases.
The company is also developing other drug candidates, including NV-CoV-2 for COVID-19 and NV-CoV-2-R, which encapsulates remdesivir. The company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. NanoViricides' business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
The Phase II trial in the DRC is expected to provide crucial data on the safety and efficacy of NV-387 in treating MPox. The company is also seeking Orphan Drug Designation from the U.S. FDA, which could provide incentives for development and potential market exclusivity. The trial announcement follows the company's earlier preclinical and clinical development efforts for NV-387.
For more information, view the full press release here.
