NanoViricides, Inc. (NYSE American: NNVC), based in Shelton, Connecticut, has announced a significant step in its clinical development pipeline by engaging a Clinical Research Organization (CRO) to facilitate a Phase II clinical trial for its broad-spectrum antiviral drug, NV-387. This initiative aims to further evaluate the drug’s potential in treating viral diseases, particularly targeting MPox, caused by the human Mpox virus (hMPXV).
The urgency of this trial is underscored by the ongoing regional pandemic of MPox, which has affected several African nations and prompted the World Health Organization (WHO) to declare a Public Health Emergency of International Concern (PHEIC) in August 2024. Currently, there are no effective treatments for hMPXV infection. Previous attempts to utilize tecovirimat (TPOXX®) have proven ineffective, as reported by the National Institutes of Health (NIH) following a clinical trial that showed no significant benefits over a placebo.
Despite the lack of efficacy demonstrated by TPOXX, it has still garnered substantial procurement contracts from U.S. government agencies, amounting to over $120 million. Anil R. Diwan, Ph.D., President and Executive Chairman of NanoViricides, criticized these expenditures as indicative of a pressing need for effective antiviral treatments amid government reliance on an ineffective drug.
NV-387 has shown promising results in preclinical studies, demonstrating strong antiviral activity against orthopoxviruses, an important factor given that MPox and Smallpox viruses belong to this family. In animal models, NV-387’s effectiveness matched that of tecovirimat in treating both skin and lung infections caused by the virus. Unlike tecovirimat, which can be circumvented by viral mutations, NV-387 is designed to mimic sulfated proteoglycans that viruses use to attach and infect cells. This unique mechanism makes it less likely for viruses to escape treatment through mutation.
The development of NV-387 represents a potential breakthrough in antiviral therapies. As a host-mimetic drug, it effectively disguises itself as a cell to attract viruses, allowing for their neutralization before they can cause harm. This innovative approach could provide a robust defense against various viral threats that continue to evolve and pose challenges beyond the capabilities of traditional vaccines and antibodies.
In addition to targeting MPox and Smallpox, NV-387 has shown efficacy in treating respiratory syncytial virus (RSV) infections in animal models and has outperformed other antiviral drugs such as oseltamivir (Tamiflu®) and baloxavir (Xofluza®) in comparative studies for influenza treatment. The company believes that as new viral strains emerge with increased pathogenicity and infectivity, broad-spectrum antiviral drugs like NV-387 will become essential components of public health strategies.
NanoViricides’ commitment to advancing NV-387 into human clinical trials reflects its broader mission to develop specialized nanomaterials for antiviral therapy. The company’s technology is based on proprietary research from TheraCour Pharma, Inc., with whom it has established collaborative agreements aimed at addressing various viral infections.
As NanoViricides progresses toward regulatory approval for NV-387, it remains focused on expanding its portfolio of antiviral candidates aimed at diseases such as COVID-19, shingles, and other viral infections. However, the company acknowledges the inherent risks associated with drug development, an endeavor characterized by lengthy timelines and substantial financial investment without guaranteed outcomes.
