NanoViricides (NYSE-A:NNVC) said on Monday it is close to finalizing the design of a Phase II adaptive clinical trial for its lead candidate NV-387 to treat MPox virus Clade 1a and 1b infections.
The trial aims to assess safety, tolerability, and antiviral effectiveness in approximately 80 patients, with the initial Phase IIa portion to be conducted at a single site in the Democratic Republic of Congo (DRC).
Phase IIb may expand to include additional African sites where MPox outbreaks are ongoing, the company said.
“This is an important milestone towards filing of the clinical trial application and starting the clinical trial,” said Anil Diwan, executive chairman of NanoViricides.
Diwan called the design “both frugal and efficient,” and said it would provide comprehensive data on NV-387’s safety and efficacy.
The Phase IIa trial will compare twice-daily oral doses of NV-387 in a soft gummy form, formulated to ease swallowing for patients with painful MPox lesions, against standard of care treatment in 20 patients. If initial data support continued dosing, treatment may extend beyond the initial six days. Phase IIb will enroll an additional 60 patients in a 2:1 randomization scheme to treatment and control arms.
The World Health Organization and the US Centers for Disease Control and Prevention have flagged MPox Clade 1 strains—circulating in central Africa—as more virulent than Clade 2 strains seen in Western countries. Clade 1a carries a case fatality rate of 3–11%, while Clade 1b has a lower, but still concerning, rate of about 1%.
MPox still lacks an effective approved treatment, as existing drugs Tecovirimat and Brincidofovir have failed in human trials. NanoViricides’ NV-387 could become the first to show clinical efficacy, and the company may seek approvals in the US, EU, and Africa, with African approval likely to come first.
NanoViricides noted that Tecovirimat has brought in more than $600 million in sales to the US government for stockpiling purposes, highlighting a potential commercial pathway for NV-387, particularly given the risk of MPox spreading beyond endemic regions.
The company said NV-387 for MPox is eligible for Orphan Drug Designation in the US, which provides development incentives including tax credits and market exclusivity.
Investors welcomed the update, sending shares of Nanoviricides 9.3% higher in early trade on Monday.