NanoViricides (NYSE-A:NNVC) said on Thursday it has received ethics committee approval in the Democratic Republic of Congo to move forward with a planned Phase II clinical trial of its antiviral drug NV-387 for treating Mpox, a step toward regulatory submission in a region where the disease continues to spread.
The approval, granted by the National Ethics Committee for Health (CNES) under the DRC’s Ministry of Public Health, clears the company to submit a full clinical trial application (CTA) for NV-387, NanoViricides said.
“We are now fully engaged in completing the detailed CTA for submission to the DRC Regulatory Agency,” said Anil Diwan, president and executive chairman of NanoViricides.
NanoViricides announced earlier this year that it had engaged a contract research organization (CRO) to conduct the Phase II trial in Africa. The trial is planned at the Medical Hospital of the University of Kinshasa, with the company, CRO, and local investigators developing a summary package including data from prior animal studies and an initial human trial.
The company says NV-387 has shown potent antiviral activity in animal models against several viruses, including orthopoxviruses like Mpox and smallpox, as well as influenza, RSV, and coronaviruses. Unlike existing antiviral drugs that viruses can escape through mutations, NV-387 mimics human cell surfaces, making viral resistance less likely, Diwan said.
“There is currently no effective drug approved for the treatment of Mpox,” he added.
Mpox, caused by the human monkeypox virus (hMPXV), has triggered a regional pandemic across the WHO African Region, including the DRC and Uganda. The World Health Organization declared it a Public Health Emergency of International Concern in August 2024, extending the designation most recently in March 2025 as cases continued to rise.
NanoViricides says NV-387, as a “host-mimetic” drug, could represent a new class of broad-spectrum antivirals that remains effective even as viruses mutate, in contrast to vaccines or small-molecule drugs that viruses can more easily evade.