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 (DRC). Site preparation and staff training are 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.
NV-387 is a broad-spectrum antiviral drug candidate that NanoViricides plans to develop for respiratory viral infections such as RSV, COVID-19, Long COVID, and influenza, as well as for MPox and smallpox infections. The company’s lead candidate is currently being advanced into Phase II human clinical trials. The upcoming trial in the DRC marks a significant step forward for the company, as it targets the more severe Clade I MPox strain prevalent in the region.
The DRC has been grappling with a significant MPox outbreak, making the initiation of clinical trials for potential treatments a critical public health priority. The Phase II trial will provide essential data on NV-387’s safety and efficacy in humans, potentially paving the way for further development and regulatory approval. NanoViricides is also seeking Orphan Drug Designation from the FDA, which could provide incentives such as tax credits and market exclusivity if the drug is approved.
NanoViricides’ platform technology is based on the TheraCour nanomedicine technology, which the company licenses exclusively for several antiviral applications. The company’s business model relies on licensing technology from TheraCour Pharma Inc. for specific viral targets. As with any drug development, there is no assurance that NV-387 will demonstrate sufficient effectiveness and safety in clinical trials.
For more information on NanoViricides, visit the company’s newsroom at https://ibn.fm/NNVC. The full press release is available at https://ibn.fm/4Ckhk.
