NanoViricides, Inc. (NYSE Amer.:NNVC) has received approval from the National Ethics Committee for Health (CNES) of the Democratic Republic of Congo (DRC) to advance its broad-spectrum antiviral drug NV-387 to Phase II clinical trials for MPox treatment. This approval clears the path for the company to submit a complete Clinical Trial Application (CTA) to the DRC's Ministry of Public Health.
"We are now fully engaged in completing the detailed CTA for the Phase II human clinical trial of NV-387 for the treatment of MPOX disease," said Anil R. Diwan, PhD, President and Executive Chairman of NanoViricides.
The development comes at a critical time as MPox continues to spread throughout the WHO African Region, including DRC and Uganda, with weekly case numbers still rising. The World Health Organization declared MPox a Public Health Emergency of International Concern (PHEIC) in August 2024, a status that has been extended twice, most recently in March 2025.
A Novel Approach to Viral Treatment
NV-387 represents a potentially revolutionary approach to antiviral therapy. Unlike conventional antivirals that target specific viral proteins, NV-387 is a host-mimetic drug designed to "look like a cell" to viruses. It displays numerous ligands that mimic sulfated proteoglycans, which are used by viruses as attachment receptors to infect cells.
"NV-387, our broad-spectrum antiviral drug is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases," explained Dr. Diwan. "This single drug can target over 90-95% of human pathogenic viruses due to this biomimicry."
The drug's mechanism involves enticing viruses to bind to its dynamic shape-shifting polymeric micelle, effectively trapping and destroying them. This approach makes viral escape through mutation highly unlikely, as viruses would need to fundamentally change how they attach to cells—a much more significant evolutionary hurdle than the point mutations that can render conventional antivirals ineffective.
Addressing a Critical Unmet Need
Currently, there are no approved treatments for MPox. In August 2024, a clinical trial of tecovirimat (TPOXX®, SIGA)—previously considered promising—failed to demonstrate effectiveness over placebo, according to a NIH press release.
The clinical trial will be conducted at the Medical Hospital at the University of Kinshasa. NanoViricides had announced in January 2025 that it had engaged a Contract Research Organization (CRO) for conducting the Phase II trial in the African Region.
Impressive Preclinical Results
NV-387 has shown remarkable efficacy in preclinical studies across multiple viral infections:
- In lethal animal models of influenza virus infection, NV-387 significantly outperformed existing drugs including Tamiflu®, Rapivab®, and Xofluza®
- Complete cure of lethal RSV lung infection in an animal model, where no approved treatment currently exists
- Superior performance compared to remdesivir in lethal coronavirus animal models
- Strong antiviral activity against orthopoxviruses in animal models considered relevant for MPox and smallpox, matching the effectiveness of tecovirimat in both skin and lung infection models
Resistance to Viral Escape
A key advantage of NV-387's approach is its potential resistance to viral escape. Conventional antivirals like tecovirimat can be rendered ineffective by a single point mutation in a viral protein. Similarly, vaccines and antibodies can lose effectiveness as viruses evolve.
In contrast, NV-387 targets a fundamental mechanism that viruses use to infect cells—their attachment to sulfated proteoglycans. As Dr. Diwan noted, "No matter how much the virus changes in the field, it continues to use sulfated proteoglycans such as HSPG as 'attachment receptor' in order to cause cell infection."
Broader Applications
While the current focus is on MPox treatment, NanoViricides is developing NV-387 as a broad-spectrum solution for multiple viral infections. The company plans to develop it for RSV, COVID, Long COVID, influenza, and other respiratory viral infections, in addition to MPox/smallpox.
The company is also advancing another drug candidate, NV-HHV-1, for the treatment of shingles.
Path Forward
With the ethics committee approval secured, NanoViricides is now preparing the detailed CTA for submission to the DRC's regulatory agency. The company, working with its CRO and the Principal Investigator at the University of Kinshasa, has already developed a comprehensive information package including the clinical trial protocol, background information on NV-387, a draft summary of the Phase I trial, and preclinical data demonstrating the drug's effectiveness against MPox.
If successful, NV-387 could represent a paradigm shift in antiviral therapy, providing a broad-spectrum solution that remains effective even as viruses evolve—addressing a critical gap in our current antiviral arsenal that has become increasingly evident during recent viral outbreaks.
