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. 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.
This trial marks a significant step for NanoViricides in addressing the ongoing MPox outbreak, particularly the more severe Clade I strain prevalent in Central Africa. The company's lead drug candidate, NV-387, is a broad-spectrum antiviral designed to treat respiratory infections such as RSV, COVID-19, Long COVID, and influenza, in addition to MPox and smallpox. The initiation of this Phase II trial underscores the potential of NV-387 to provide a much-needed therapeutic option against MPox, which has been declared a Public Health Emergency of International Concern by the World Health Organization.
For more details, refer to the full press release at https://ibn.fm/4Ckhk. According to the company, NV-387 is a novel nanoviricide drug candidate that does not encapsulate remdesivir, distinguishing it from other candidates like NV-CoV-2-R, which combines NV-387 with remdesivir. The company believes that since remdesivir is already FDA approved, their candidate encapsulating remdesivir could be approvable if safety is comparable.
The company is also developing drugs against a number of viral diseases including oral and genital herpes, viral eye diseases, H1N1 swine flu, H5N1 bird flu, seasonal influenza, HIV, Hepatitis C, rabies, dengue fever, and Ebola virus. NanoViricides' platform technology and programs are based on TheraCour nanomedicine technology, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms for treating a range of human viral diseases.
As with any drug development, there can be no assurance at this time that any of the company's pharmaceutical candidates will show sufficient effectiveness and safety for human clinical development. The company must also state the risk factor that the path to typical drug development is extremely lengthy and requires substantial capital. Further, there can be no assurance that successful results against coronavirus in their lab will lead to successful clinical trials or a successful pharmaceutical product.
Investors can find the latest news and updates relating to NNVC in the company's newsroom at https://ibn.fm/NNVC. This development highlights NanoViricides' commitment to advancing antiviral therapeutics and addressing unmet medical needs in global health.
