NanoViricides (NYSE-A:NNVC) said on Monday it signed a master services agreement with regulatory consulting firm Only Orphans Cote LLC to support the company’s orphan drug strategy for its broad-spectrum antiviral candidate NV-387.
The firm, founded by former US Food and Drug Administration official Dr Timothy Cote, will help develop and prosecute orphan drug designation applications for NV-387 at the FDA’s Office of Orphan Products, NanoViricides said.
“In earlier discussions with Dr Cote, it became apparent that the broad-spectrum antiviral drug NV-387 could harness several benefits from an orphan drug regulatory strategy,” Anil Diwan, the company’s president and executive chairman, said in a statement.
NanoViricides said NV-387 has shown strong activity in lethal animal models of orthopoxvirus infection, supporting a potential regulatory pathway for use in smallpox. Smallpox is considered a bioterrorism threat despite being eradicated globally in 1980, and the company expects NV-387 to be eligible for orphan drug designation for that indication.
The company also said mpox, caused by the monkeypox virus, qualifies as an orphan disease in the US, and that it believes NV-387 could be eligible for designation for that use as well.
According to NanoViricides, NV-387 is also the only known drug candidate to show in vivo activity against measles in a humanized animal model.
The US Centers for Disease Control and Prevention has reported 1,798 confirmed cases of measles across 42 states so far this year, and officials warn the country could lose its measles elimination status in 2026 if current trends continue.
Orphan drug designation provides incentives such as tax credits for clinical trials, exemption from user fees and seven years of market exclusivity following approval.
Dr Cote previously served as director of the FDA’s Office of Orphan Products Development.
NanoViricides describes NV-387 as a broad-spectrum antiviral that has shown effectiveness in animal models of RSV, COVID-19, influenza, mpox, smallpox and measles.