NanoViricides Set to Begin Phase II Trial for Monkeypox Treatment

NanoViricides, Inc. announced plans to commence a Phase II clinical trial for its monkeypox treatment, NV-387, in the Democratic Republic of Congo. This decision follows regulatory approval by DRC's ACOREP. The trial will assess the safety and effectiveness of NV-387, specifically targeting MPox Clade I, a more severe form of the virus endemic in the region.

The trial preparations, led by Om Sai Clinical Research Pvt. Ltd., a CRO based in India, are underway, with patient enrollment and dosing expected soon. Anil R. Diwan, President of NanoViricides, emphasized the significance of this milestone in NV-387's regulatory development.

In the U.S., NV-387 could potentially gain Orphan Drug Designation, offering financial and regulatory incentives. The drug holds promise as a potential pandemic response tool, amid concerns of increasing MPox Clade I cases in the U.S. and limitations of current vaccines and treatments.