NV-387 (gummies)

August 18, 2026: NanoViricides, Inc. (NYSE American: NNVC) said it received local regulatory approval from ACOREP in the Democratic Republic of Congo to start a Phase II trial of NV-387 Oral Gummies for treatment of the current Bundibugyo ebolavirus outbreak and other Ebola viruses. The company appointed Professor Patrick Katoto as principal investigator, and said preparatory work and staff training are already underway.

NanoViricides said trial drug supply is already in the DRC, originally shipped for an impending Phase II mpox trial, and expects first Ebola patient dosing within a few weeks, subject to outbreak-related disruptions. Om Sai Clinical Research Private Limited is the CRO for both the Ebola and mpox Phase II studies in DRC.

The release describes the outbreak as rapidly expanding, citing 4,945 confirmed cases and 2,325 deaths as of August 14, 2026, with a crude fatality rate of 46% and WHO’s May 17, 2026 declaration of a PHEIC. It also notes other ongoing DRC efforts, including the WHO-backed PARTNERS trial, where first patient dosing occurred July 2, 2026, evaluating remdesivir infusion, MBP134 infusion, and the combination, plus a Bundibugyo-specific Oxford vaccine trial.