NanoViricides, Inc. (NYSE American: NNVC) has announced that a Phase II clinical trial for its antiviral candidate NV-387 targeting MPox is expected to commence soon in the Democratic Republic of Congo. Site preparation and staff training are scheduled for early April 2026. The study, which has already received approval from the DRC regulatory agency, will evaluate the safety and effectiveness of NV-387 against Clade I MPox. The company is advancing regulatory development and seeking Orphan Drug Designation from the U.S. Food and Drug Administration.
NV-387 is a broad-spectrum antiviral drug that NanoViricides plans to develop for multiple respiratory viral infections, including RSV, COVID-19, Long COVID, and Influenza, in addition to MPox and Smallpox infections. The company's development pipeline includes another advanced candidate, NV-HHV-1, for the treatment of Shingles. NanoViricides is a clinical-stage company creating special purpose nanomaterials for antiviral therapy, with its novel nanoviricide class of drug candidates based on technology from TheraCour Pharma, Inc.
The company's platform technology and programs are built on the TheraCour nanomedicine technology, which NanoViricides holds exclusive perpetual licenses for several viral diseases. These include Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B and C viruses, Rabies, Herpes Simplex Virus, Influenza, Dengue viruses, Ebola/Marburg viruses, and certain Coronaviruses. The company intends to obtain licenses for RSV, Poxviruses, and/or Enteroviruses if initial research proves successful.
For COVID-19 specifically, NanoViricides has developed two drug candidates: NV-CoV-2 (API NV-387) and NV-CoV-2-R, which encapsulates remdesivir within its polymeric micelles. The company believes that since remdesivir is already FDA-approved, their drug candidate encapsulating it may have a clearer regulatory pathway if safety profiles are comparable. The company's business model involves licensing technology from TheraCour Pharma Inc. for specific application verticals of particular viruses, as established at its foundation in 2005.
The initiation of the Phase II MPox trial in the Democratic Republic of Congo represents a significant step in addressing viral diseases that pose global health challenges. MPox, particularly the Clade I variant prevalent in Central Africa, has caused ongoing outbreaks with limited treatment options available. The development of effective antiviral therapies could have substantial implications for public health systems in affected regions and contribute to global pandemic preparedness. As with all pharmaceutical development, the path from clinical trials to approved products is lengthy and capital-intensive, with no guarantee of success, but this advancement represents progress in the fight against viral pathogens with pandemic potential.
