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

We reported that we submitted requisite due diligence information to the National Ethics Committee of the Democratic Republic of Congo (DRC) including a draft report from the Phase I clinical trial for the safety and tolerability of oral formulations of NV-387, the summary information from our studies for treatment of lethal MPox infections in animal models, as well as summary information on the manufacturing.

The National Ethics Committee found that the provided information was sufficient to justify a Phase II clinical trial, and has cleared us to file a Phase II Clinical Trial Application for the Use of Oral NV-387 for the Treatment of MPox Disease Caused by the hMPXV virus, subsequent to the reporting period.

We also reported that we have commissioned manufacture of clinical trial quantities of NV-387 drug substance and the corresponding NV-387 oral gummies formulations drug products at our own cGMP compliant facility in Shelton, CT.

We are now preparing the Phase II Clinical Trial Application for NV-387 to combat MPOX for submission to the DRC regulatory agency.

There is no drug available for the treatment of MPox disease. The MPox Clade 1a/1b viruses have a substantially greater fatality rate than COVID, at 3-4%, and Clade 1b has been disproportionately affecting pediatric populations.

The MPox Disease which is caused by hMPXV Clade 1a/1b virus infection was initially declared a Public Health Emergency of International Concern (PHEIC) by the WHO in August 2024, a designation that has been continued to stay in effect in April 2025, due to the severity of the pandemic in WHO African Region.

Spillover cases of MPox Clade 1a/1b have occurred in several Eastern and Western countries already, raising the probability that the epidemic may spread more widely, although the current MPox virus is not as communicable as Coronaviruses or Measles virus.

MPox Clade 2 spilled over from Africa into the Western World in a small pandemic during 2022, and has become endemic with several cases occurring every year in many countries, driven primarily by sexual contact. MPox Clade 2 causes much less severe disease than the Clade 1a and 1b viruses.

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