NanoViricides Nears Completion of Adaptive Trial Design for MPox Drug NV-387

NanoViricides, Inc. is finalizing an adaptive clinical trial protocol for NV-387. This novel drug aims to treat MPox Clade Ia and Ib infections. The design includes safe dosing, drug safety, and antiviral effectiveness. The trial will engage about 80 patients, marking a crucial step towards a clinical trial application.

The clinical trial, set in two phases, will first occur in the Democratic Republic of Congo. Initial results from Phase IIa will determine dosing for Phase IIb. NV-387 could become the first effective human-tested drug for an orthopoxvirus if successful. This oral gummy formulation fits patients with eating difficulties due to lesions.

No currently approved drugs effectively treat MPox. NV-387's success could lead to U.S. FDA Orphan Drug Designation, pursuing global regulatory approvals. The trial also covers experimental comparisons with standard healthcare practices, underscoring the efficiency and resourcefulness of its design.