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.
This development marks a significant step for NanoViricides, which is a clinical stage company creating special purpose nanomaterials for antiviral therapy. NV-387 is a broad-spectrum antiviral drug that the company plans to develop as a treatment for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. The upcoming trial in the DRC is particularly important because Clade I MPox is known to be more severe than other clades, and effective treatments are urgently needed.
The company's platform technology is based on the TheraCour(R) nanomedicine technology, which NanoViricides holds a worldwide exclusive perpetual license for several drugs with specific targeting mechanisms. This includes treatments for a range of viral diseases such as HIV/AIDS, Hepatitis B and C, Rabies, Herpes Simplex Virus, Varicella-Zoster Virus, Influenza, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if initial research is successful.
NanoViricides' lead drug candidate NV-387 is also being developed for COVID-19 under the name NV-CoV-2, which does not encapsulate remdesivir, and NV-CoV-2-R, which encapsulates remdesivir. The company believes that since remdesivir is already US FDA approved, NV-CoV-2-R could be an approvable drug if safety is comparable. Additionally, the company is developing drugs against oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.
The initiation of the Phase II trial is a critical milestone for NanoViricides as it seeks to demonstrate the clinical utility of its nanoviricide technology. The company's business model relies on licensing technology from TheraCour Pharma Inc. for specific application verticals, established at its foundation in 2005. However, as with any drug development, there are inherent risks. The path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. There can be no assurance that any of the company's pharmaceutical candidates will show sufficient effectiveness and safety for human clinical development, or that successful lab results will lead to successful clinical trials or a pharmaceutical product.
For more information, the full press release is available at https://ibn.fm/4Ckhk. The latest news and updates relating to NNVC can be found in the company's newsroom at https://ibn.fm/NNVC.
