NanoViricides (NYSE-A:NNVC), a clinical-stage biotechnology company developing broad-spectrum antiviral therapies, has filed for Orphan Drug Designation (ODD) with the US Food and Drug Administration (FDA) for its lead candidate NV-387 as a treatment for MPox.
If granted, the designation could provide NanoViricides with tax credits for clinical trials, exemption from certain user fees, and up to seven years of market exclusivity after approval.
“NV-387, as an effective drug, would be an important tool to fight MPox in the USA and worldwide, when approved after clinical trials,” said executive chairman Anil Diwan. Diwan noted that MPXV Clade IIb is currently endemic in the United States, while the more contagious Clade Ia/Ib continues to circulate in Africa and poses a potential global pandemic threat.
The World Health Organization previously declared MPox a Public Health Emergency of International Concern in 2022 and again in 2024 due to the spread of different MPXV clades. Although those declarations were later lifted, the Africa CDC continues to classify MPox as a Public Health Emergency of Continental Security because of ongoing viral spread.
Currently, there are no FDA-approved treatments for MPox.
NV-387, which has completed a Phase I human clinical trial demonstrating safety and tolerability, has shown strong antiviral activity in animal models of orthopoxvirus infections closely related to MPox and smallpox. The drug is designed to mimic human cell surfaces, allowing it to bind to, engulf, and destroy virus particles without relying on the immune system.
The company said its application for Orphan Drug Designation was developed with regulatory consulting firm Only Orphans Cote, LLC, led by Dr Timothy Cote, a former director of the FDA’s Office of Orphan Products Development.