NanoViricides, Inc. (NYSE American: NNVC), a leader in the development of broad-spectrum antiviral therapies, has announced the near-finalization of its adaptive clinical trial protocol for MPox Clade Ia and Ib. This innovative trial design targets approximately 80 patients in the Democratic Republic of Congo, focusing on the safety, dosing, and efficacy of NV-387 oral gummies. These gummies are specifically formulated to simplify administration for patients suffering from painful oral lesions, a common symptom of MPox.
The significance of NV-387 lies in its potential to become the first drug demonstrating clinical efficacy against an orthopoxvirus in humans. Success in this trial could pave the way for NanoViricides to seek regulatory approvals not only in Africa but also in the U.S. and globally, including for the treatment of smallpox. This development is particularly noteworthy given the limitations of existing treatments such as Tecovirimat and Brincidofovir, which have shown poor efficacy or adverse events in previous trials.
Moreover, the ongoing threat of Clade 1b MPox in Africa, which remains a transmissible epidemic risk and poses a potential threat to Western nations, underscores the urgent need for effective treatments. NanoViricides' progress with NV-387 represents a critical step forward in addressing this unmet medical need and could have far-reaching implications for global health security.
