NanoViricides (NYSE-A:NNVC) said on Wednesday that its broad-spectrum antiviral candidate NV-387 has shown strong preclinical efficacy against multiple viruses, positioning it as a potential tool in global pandemic preparedness.
The Connecticut-based biotech firm said its NV-387 compound has demonstrated effectiveness in animal studies against a wide range of viral threats, including MPox, Smallpox, Measles, Influenza, Coronaviruses, and other orthopoxviruses.
The company is preparing to initiate a Phase II clinical trial for NV-387 in the treatment of MPox, which could make it the first drug ever approved for the disease.
“There is no effective drug for MPox at present,” the company said in a statement, adding that approval for the indication could also support use against smallpox, given the similarity between the viruses.
NanoViricides plans to seek orphan drug designation in the United States for several indications, including MPox, Smallpox and Measles. The company believes that these designations could provide regulatory benefits such as market exclusivity and potential Priority Review Vouchers (PRVs), which have traded in the past for between $150 million and $250 million.
The firm emphasized that the cost of advancing NV-387 through early clinical development would be shared across multiple viral indications, improving return on investment. It said the drug could be eligible for fast-track designation, expediting its development timeline.
NV-387 is based on NanoViricides’ host-mimetic nanomedicine platform, which uses a decoy molecule designed to mimic HSPG, a cellular target that over 90% of pathogenic viruses bind to in order to infect humans. The company said this approach offers broad-spectrum protection and makes viral escape through mutation highly unlikely.
NanoViricides also said it is continuing to plan trials for other commercially significant respiratory viruses such as RSV, Influenza, and Coronaviruses.