NanoViricides, Inc. Has Filed its Quarterly Report: Broad-Spectrum Antiviral NV-387 To Combat MPox Pandemic in Africa - Phase II Clinical Trial Update, Also Readying to Combat Measles Outbreaks, and to Tackle Bird Flu
May 16, 2025
The continued lack of an effective antiviral treatment for mpox, especially the severe Clade 1a and 1b strains, highlights a critical unmet medical need in global public health. With case fatality rates as high as 3–4%—and children disproportionately affected—current responses rely solely on vaccines and supportive care. NanoViricides' Phase II trial of NV-387 in the Democratic Republic of Congo marks a significant step forward. If successful, NV-387 could become the first targeted oral antiviral for mpox, fulfilling a long-standing treatment gap and reinforcing global health security amid a persistent public health emergency.
Despite escalating global concern over mpox—particularly the deadly Clade 1a and 1b strains circulating in Africa—no approved antiviral treatment exists for this growing threat. The World Health Organization has continued its designation of mpox as a Public Health Emergency of International Concern through April 2025, underscoring the severity of the situation, particularly in the Democratic Republic of the Congo (DRC), where pediatric deaths are rising and testing infrastructure remains under-resourced.
In this urgent context, the announcement that NanoViricides has received ethical clearance to proceed with a Phase II trial for its oral antiviral candidate NV-387 in the DRC is a crucial development. The company previously submitted data on NV-387's safety profile and efficacy in animal models showing protection against lethal mpox infection. NV-387 is being developed as an oral gummy formulation, which could vastly improve treatment access and compliance in outbreak zones.
Unlike mpox Clade 2, which spread globally in 2022 through mostly sexual transmission and now causes sporadic, less severe disease, Clade 1a and 1b are highly virulent, with mortality rates of 3–4%—comparable to or higher than early COVID-19 strains. The stakes are particularly high for African nations where health systems are fragile and outbreaks are further complicated by armed conflict and funding shortfalls.
If successful, NV-387 would not only fill a dire therapeutic void but also address the biosecurity implications of orthopoxviruses globally. The development of an effective antiviral could complement vaccination efforts, strengthen outbreak response, and help mitigate future pandemic risks. The world must rally behind clinical efforts like NV-387, as the unmet need for effective mpox therapeutics grows ever more pressing.