NanoViricides (NYSE-A:NNVC) is preparing for Phase II clinical testing in Africa, following the World Health Organization’s recent extension of the Public Health Emergency of International Concern (PHEIC) for the Mpox virus outbreak.
The extension, announced on July 10, comes amid rising cases of the Clade I strain of the Mpox virus (MPXV) in Africa, and sporadic travel-related cases outside the region, including the US, that pose a risk of sustained transmission.
“Our development of NV-387 towards Phase II clinical trial for treatment of Mpox is timely,” said Anil Diwan, president and executive chairman of NanoViricides. “If successful, this trial could also open up a multi-billion-dollar global market of preparedness for poxvirus bioterrorism.”
Currently, no antiviral is approved and proven safe and effective in humans for treating Mpox, the company said. NanoViricides cited studies showing that tecovirimat and brincidofovir, two antivirals previously approved for smallpox under the US FDA’s “Animal Rule,” have shown limited effectiveness or adverse safety outcomes in Mpox patients.
NV-387 is designed to mimic a component of human cells called heparan sulfate proteoglycans, which viruses typically bind to before infecting cells. According to the company, this host-mimetic mechanism makes NV-387 resistant to viral escape through mutation. The drug has shown strong safety in preclinical studies and a Phase I human trial and is formulated as orally dissolving gummies for easier use in patients with oral lesions.
The upcoming Phase II trial in Africa will compare NV-387 to standard-of-care treatments, focusing on dose optimization, safety, and antiviral effectiveness.
Mpox cases continue to rise in parts of Africa, with the Clade Ib strain dominating most regions and Clade IIb prevalent in Sierra Leone.
NanoViricides said a successful trial could position NV-387 for inclusion in strategic national stockpiles, such as those in the US, and tap into broader markets for pandemic and bioterrorism preparedness.
The WHO first declared a PHEIC for Mpox in August 2024 and extended it in February 2025. The latest extension comes as the virus continues to spread across borders, with concerns about wider global transmission.
Shares of Nanoviricides jumped almost 12% on the update, trading hands at $1.65 on Wednesday morning.