NanoViricides Advances MPox Treatment with Adaptive Trial Design for NV-387

NanoViricides, Inc. (NYSE American: NNVC) has announced the near-finalization of its adaptive clinical trial protocol for MPox Clade Ia and Ib, targeting approximately 80 patients in the Democratic Republic of Congo. This two-part Phase II trial aims to evaluate the safety, dosing, and efficacy of NV-387 oral gummies, designed to facilitate administration for patients suffering from painful oral lesions. NV-387 stands to become the first drug demonstrating clinical efficacy against an orthopoxvirus in humans, marking a pivotal advancement in antiviral treatment.

The success of NV-387 could lead NanoViricides to pursue regulatory approvals across Africa, the U.S., and globally, including for smallpox. This development is particularly significant given the limitations of existing treatments such as Tecovirimat and Brincidofovir, which have shown poor efficacy or adverse effects in trials. The company also highlighted the ongoing threat posed by Clade 1b MPox in Africa, which remains a transmissible epidemic risk with potential implications for Western nations.