NanoViricides, Inc. (NYSE American: NNVC) has received approval from the Democratic Republic of Congo’s regulatory agency, ACOREP, to begin a Phase II clinical trial of its lead drug candidate NV-387 for the treatment of MPox caused by hMPXV infection. The trial will evaluate the safety and effectiveness of the drug, pending final document submissions. This approval marks a significant step forward in the development of NV-387, which the company believes could become a major breakthrough in antiviral therapy, akin to how antibiotics revolutionized the treatment of bacterial diseases.
“This is an important milestone in regulatory development of NV-387,” said Anil R. Diwan, PhD, President and Executive Chairman of NanoViricides. The drug is designed to mimic human cells, trapping and destroying viruses, and has shown potential as a broad-spectrum antiviral targeting up to 95% of human pathogenic viruses. The company plans to develop NV-387 for a range of viral infections, including RSV, COVID, Long COVID, Influenza, and MPox/Smallpox.
The Phase II trial in the DRC is a critical step in bringing NV-387 to market. The company’s novel nanoviricide class of drug candidates is based on intellectual property and technology licensed from TheraCour Pharma, Inc. NanoViricides holds exclusive, sub-licensable field licenses for several drugs targeting specific viruses, including HIV, Hepatitis B and C, Rabies, Herpes, Influenza, Dengue, and Ebola, among others.
The company’s business model relies on licensing technology from TheraCour for specific application verticals, a strategy established at its foundation in 2005. While NanoViricides is focused on advancing NV-387 into human clinical trials, it also has other drug candidates in development, such as NV-HHV-1 for Shingles, and is exploring treatments for oral and genital Herpes, viral eye diseases, and other viral infections.
As with any drug development, the path to a commercial product is lengthy and requires substantial capital. The company cautions that there can be no assurance that NV-387 or any of its other candidates will demonstrate sufficient effectiveness and safety for human clinical development or receive regulatory approval.
For more information, visit the company’s newsroom at https://ibn.fm/NNVC and the full press release at https://ibn.fm/WdFf1.
