NanoViricides, Inc. (NYSE-A:NNVC) is poised to begin Phase II clinical trials for its lead antiviral drug candidate, NV-387, in 2025. The trials will focus on MPox, viral acute respiratory infections, and potentially pediatric Respiratory Syncytial Virus (RSV). This advancement follows the successful completion of a Phase Ia/Ib clinical trial in late 2023, where NV-387 demonstrated a strong safety profile.
Targeting MPox in Africa
With the World Health Organization having declared MPox a Public Health Emergency of International Concern in August 2024, NanoViricides is prioritizing the development of NV-387 for this disease. The company has engaged a Clinical Research Organization (CRO) to manage the Phase II trial, with trial sites identified in the Democratic Republic of Congo and Uganda, where MPox is currently causing a regional pandemic. "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," said Anil Diwan, president and executive chairman of NanoViricides.
Addressing Viral Respiratory Infections and RSV
Beyond MPox, NanoViricides is also preparing to initiate a Phase II trial for NV-387 in viral acute respiratory infections, an area of significant global medical need. The company is also working towards a pre-Investigational New Drug (pre-IND) filing with the FDA for an RSV indication, specifically targeting pediatric patients. Efficacy has been demonstrated in animal studies.
NV-387 as a Countermeasure Against H5N1 Bird Flu
NanoViricides is also focusing on preparing NV-387 as a potential countermeasure against the emerging H5N1 bird flu threat. Given the virus’s rapid mutation rate and the limitations of current vaccines, the company believes its broad-spectrum antiviral could play a crucial role in pandemic preparedness.
Financial Considerations
As of early 2025, NanoViricides reported approximately $7.5 million in available funding, sourced from an at-the-market offering and a $3 million credit line. The company acknowledges that additional capital will be necessary to sustain operations through 2026 and fully execute its clinical development plans.
Differentiating NV-387 from Existing Antivirals
NanoViricides emphasizes NV-387's unique mechanism of action, which involves mimicking host cell structures to lure viruses into binding with the drug instead of healthy cells. This approach, the company believes, makes NV-387 particularly well-suited to address emerging viral threats that often evade vaccines and traditional antiviral drugs. Unlike tecovirimat, which can be bypassed by a single viral mutation, NV-387 targets the virus’s reliance on host-cell attachment mechanisms, reducing the likelihood of resistance. NanoViricides highlighted the drug’s versatility, citing its superior performance in a lethal influenza lung infection model compared to established treatments like oseltamivir (Tamiflu) and baloxavir (Xofluza).
