NanoViricides (NYSE-A:NNVC) announced that it has received approval to begin its Phase II Clinical Trial of NV-387 for the Treatment of MPox by the Regulatory Agency ACOREP of the Democratic Republic of Congo (DRC).
The clinical stage biotechnology company said the proposed Phase II clinical trial to evaluate safety and effectiveness of NV-387 for the treatment of patients with MPox disease caused by hMPXV infection is now cleared to proceed subject to filing of certain documents.
"NV-387, our broad-spectrum antiviral drug, is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases," NanoViricides executive chairman Anil Diwan said in a statement.
"This single drug can target over 90-95% of human pathogenic viruses due to this biomimicry, which is reminiscent of the antibiotic penicillin that targets a large number of human pathogenic bacteria."
NanoViricides noted that there is no drug available for the treatment of hMPXV infection that causes the MPox disease.
NV-387, which is designed to mimic human cells to trap and destroy the virus, was found to be highly effective in increasing survival in lethal animal models of the influenza virus, surpassing existing drugs Tamiflu, Rapivab and Xofluza by a large margin, according to the company.
NanoViricides added that in May 2025, that it had received an approval from the Ethics Committee CNES of the national regulatory agency in DRC that NV-387 can be considered for a Phase II clinical trial for the treatment of MPox.
Shares of NanoViricides were up around 3.3% just after Monday's opening bell.