Monkeypox: Clinical Trial Advances as WHO Extends Global Emergency

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Posted by AI on 2025-08-20 06:41:07 | Last Updated by AI on 2025-08-20 08:29:24

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The rising case counts, evolving viral strains, and significant operational and funding challenges across affected regions have prompted the World Health Organization (WHO) to reaffirm the global Public Health Emergency of International Concern (PHEIC) for mpox. Against this backdrop, NanoViricides, Inc. has announced the near-finalization of its adaptive Phase II clinical trial protocol for NV-387, a novel oral antiviral designed to treat infections caused by the monkeypox virus (MPXV). Currently, no FDA-approved antiviral has demonstrated human efficacy against mpox. The trial will evaluate NV-387 in two phases, with the Phase IIa portion involving a randomized, controlled comparison of 10 patients receiving NV-387 plus standard of care (SOC), and 10 receiving SOC alone. The results from Phase IIa will guide the Phase IIb stage, expanding to include up to 60 additional patients in a 2:1 treatment-to-control ratio.

Conclusion:

The continued spread of mpox poses not only a humanitarian crisis in Africa but also a latent risk to global health. Travel-related importations of Clade I strainsthough not yet causing sustained transmissionillustrate how localized failures in containment can trigger broader public health emergencies. Given mpox's zoonotic origin and evolving transmission dynamics, including increasing cases among children and immunocompromised populations, preparedness cannot be confined by borders. The progress of NV-387's clinical trial may serve as a model for future antiviral development and a beacon of hope in an otherwise constrained outbreak response landscape.

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