Phase II Clinical Trial for NV-387 in Mpox Treatment Commences in DRC

NanoViricides, Inc. has initiated a Phase II clinical trial for its antiviral drug, NV-387, targeting Monkeypox virus infection in the Democratic Republic of Congo (DRC). The trial is registered under PACTR202609506749917 in the Pan African Clinical Trials Registry. This study aims to assess the safety and efficacy of NV-387, administered as oral gummies, in comparison to the standard of care in MPox patients.

Prof. Vivi Maketa Tevuzula is leading the trial, which unfolds in Lodja, a remote Sankuru province. Maketa's team is supported by Indian CRO, Om Sai Clinical Research. NV-387 is anticipated to become significant in pandemic response, contingent on success in current trials.

Notably, no approved treatment exists for Mpox. NV-387's success could align it with the US Government's strategic stockpiling contracts, unlocking substantial economic opportunities for the company. NanoViricides has applied for Orphan Drug Designation from the US FDA, hopeful for enhanced benefits and marketing exclusivity.