NanoViricides (NYSE-A:NNVC) said on Wednesday it expects to begin a Phase II clinical trial of its antiviral candidate NV-387 for the treatment of mpox in the Democratic Republic of Congo (DRC) shortly.
The company said site preparations are underway, led by contract research organization Om Sai Clinical Research and local partners in the DRC.
Personnel from the CRO are scheduled to visit the trial site in the first week of April 2026 for final preparations and staff training, after which patient enrollment and dosing are expected to begin.
NanoViricides previously received authorization from the DRC’s regulatory agency, ACOREP, to proceed with the Phase II study.
The trial will evaluate the safety and effectiveness of NV-387 in patients infected with human monkeypox virus (hMPXV). The study is expected to focus on MPox Clade I, a more severe strain that is endemic in the DRC.
“This is an important milestone in regulatory development of NV-387,” said Anil R. Diwan, the company’s president and executive chairman.
Mpox is classified as an orphan disease in the US, and NanoViricides said it has applied to the US Food and Drug Administration for orphan drug designation for NV-387. If granted, the designation could provide regulatory and financial incentives, including fee waivers, tax credits and market exclusivity upon approval.
NanoViricides said NV-387 demonstrated antiviral activity in animal models of orthopoxvirus infections, with effectiveness comparable to tecovirimat in certain settings.
Mpox remains endemic in parts of Africa, while cases of Clade I infection have also been reported in the United States, including instances without travel history, according to data cited from the US Centers for Disease Control and Prevention.
The company said it believes NV-387 could play a role in pandemic preparedness if the trial is successful.