NanoViricides, Inc. (NYSE American: NNVC) announced continued progress in advancing its broad-spectrum antiviral drug candidate NV-387 toward a Phase II clinical trial for the current Bundibugyo ebolavirus outbreak in the Democratic Republic of the Congo (DRC). The company stated that its proposed trial has been approved by the DRC Pillar Committee, with preparations underway for ethics and regulatory submissions.
NV-387 is being developed as an oral gummies formulation, which NanoViricides notes is the only orally administered Ebola treatment candidate currently under consideration for clinical trials. This formulation could offer significant advantages in resource-limited outbreak settings where infusion-based therapies are difficult to deploy.
The DRC outbreak continues to expand, with 1,561 confirmed cases and 506 deaths reported as of July 6, according to the company. No approved treatment or vaccine currently exists for the Bundibugyo strain, underscoring the urgent need for therapeutic options.
NanoViricides believes NV-387's broad-spectrum antiviral mechanism may provide activity against multiple ebolavirus strains. The same oral gummies formulation has already received approval from DRC regulators for a Phase II trial in Mpox, with product shipped to the country for that study.
The company’s lead drug candidate, NV-387, is also being developed to treat RSV, COVID-19, Influenza, and other respiratory viral infections. The company holds a worldwide exclusive perpetual license to TheraCour nanomedicine technology for several viral diseases, including Ebola and Marburg viruses.
As with any drug development, NanoViricides cautions that there can be no assurance that NV-387 will show sufficient effectiveness and safety for human clinical development or lead to a successful pharmaceutical product.
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