NanoViricides, Inc. (NYSE American: NNVC) has received regulatory approval from ACOREP, the local regulatory agency in the Democratic Republic of Congo (DRC), to begin a Phase II clinical trial of NV-387 Oral Gummies as a treatment for the current Bundibugyo ebolavirus outbreak and other Ebola viruses. The company has engaged Om Sai Clinical Research Private Limited as the contract research organization for the study, with initial trial preparations already underway to accelerate first patient dosing. According to the company, sufficient quantities of NV-387 Oral Gummies to begin the trial are already in the DRC.
NV-387 is an investigational broad-spectrum antiviral designed to mimic host-side features required by viruses for infection. The oral formulation could offer significant advantages in resource-limited outbreak settings compared with treatments requiring intravenous infusion. The company cited World Health Organization data showing 4,141 confirmed cases and 1,889 confirmed deaths from the current Bundibugyo ebolavirus outbreak in the DRC as of Aug. 6, 2026.
This approval marks a critical step in addressing a deadly outbreak with a novel therapeutic approach. Currently, Ebola treatments are typically administered intravenously, which can be challenging in regions with limited healthcare infrastructure. An oral gummy formulation could simplify administration, potentially allowing for broader distribution and easier compliance, which is vital in controlling outbreaks. Moreover, NV-387's broad-spectrum antiviral mechanism suggests it could be effective against multiple strains of Ebola and other viruses, offering a versatile tool in pandemic preparedness.
The trial's progress will be closely watched by the global health community. If successful, NV-387 could become a key asset in the fight against Ebola and other viral threats. NanoViricides' focus on developing an oral antiviral is particularly timely given the ongoing outbreak and the need for effective, accessible treatments. The company's ability to rapidly initiate the trial, with product already in the DRC, underscores its commitment to addressing urgent public health needs.
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