NanoViricides Receives DRC Approval To Start Phase II Trial Of NV-387 For MPox Treatment

NanoViricides, Inc. (NYSE:NNVC) (the "Company") today reported that it has received approval to Start Phase II Clinical Trial of NV-387 for the Treatment of MPox by the Regulatory Agency ACOREP of the Democratic Republic of Congo (DRC).

The proposed Phase II clinical trial to evaluate safety and effectiveness of NV-387 for the treatment of patients with MPox disease caused by hMPXV infection is now cleared to proceed subject to filing of certain documents.

"This is an important milestone in regulatory development of NV-387," said Anil R. Diwan, PhD, President and Executive Chairman of the Company.

There is no drug available for the treatment of hMPXV infection that causes the MPox disease. A clinical trial of tecovirimat (TPOXX®, SIGA) failed to demonstrate any effectiveness over placebo, as per a NIH press release on August 15, 2024. Another drug, brincidofovir (TEMBEXA ®, EBS) entered into a clinical trial called "MOSA" with fanfare in January, 2025, with early topline results expected by the end of the quarter. The status of this clinical trial is not publicly known as of now.

MPox Clade II has become endemic in the USA but it affects a limited population of Men-having-Sex-with-Men (MSM), because of transmission during sexual activity.

Most recently, three new cases of MPox Clade I have been found in California in unconnected persons, with no travel to Africa; yet the MPXV viral genomes were found to be in the same cluster, suggesting that community spread of the MPXV Clade I is likely already occurring, according to the CDC (https://www.aha.org/news/headline/2025-10-29-cdc-says-3-cases-severe-mpox-california-may-be-linked-august-case).