NanoViricides Receives DRC Approval to Advance Proposed Phase II Ebola Trial

NanoViricides, Inc. (NYSE American: NNVC) announced that the Pillar Committee in Charge in the Democratic Republic of Congo has approved the company's proposal to conduct a Phase II clinical trial evaluating NV-387 Oral Gummies as a treatment for the current Bundibugyo ebolavirus outbreak. The company said NV-387 is a broad-spectrum antiviral designed to target host-cell features required by viruses and is the only orally administered Ebola treatment candidate currently under consideration for clinical testing, to its knowledge.

NanoViricides said the next steps include obtaining approvals from the DRC National Ethics Committee and regulatory agency ACOREP before initiating the study. The company noted that NV-387 Oral Gummies have already received authorization in the DRC for a Phase II mpox trial and are ready for shipment. Management believes the oral formulation could offer significant advantages in resource-limited outbreak settings, where intravenous treatments can be difficult to deploy and scale.

The approval from the DRC's Pillar Committee is a critical milestone for NanoViricides as it advances its lead drug candidate NV-387. The company has been developing this broad-spectrum antiviral for multiple viral infections, including COVID-19, mpox, and Ebola. The oral gummy formulation is particularly notable because it could simplify administration in outbreak zones, potentially improving patient compliance and reducing the need for trained medical personnel to administer injections.

The Bundibugyo ebolavirus outbreak in the DRC highlights the ongoing threat of Ebola in Africa. According to the World Health Organization, the current outbreak was declared in August 2022, and while it has been contained to a limited area, the need for effective treatments remains urgent. Intravenous therapies like monoclonal antibodies and remdesivir require cold chain logistics and healthcare infrastructure that are often lacking in remote regions. An oral treatment could be stockpiled and distributed more easily, enabling faster response to future outbreaks.

NanoViricides' NV-387 targets host-cell features common to many viruses, which could make it effective against multiple viral families. The company has already initiated a Phase II mpox trial in the DRC using the same oral gummy formulation, which could provide additional safety and efficacy data. If successful, NV-387 could become a key tool in pandemic preparedness, offering a portable and easy-to-administer option for viral diseases that emerge in resource-limited settings.

The company's technology is based on nanoviricide drug candidates that use polymeric micelles to deliver antiviral payloads. NV-387 is the unencapsulated form, while NV-CoV-2-R encapsulates remdesivir. NanoViricides holds exclusive licenses from TheraCour Pharma for several antiviral applications. The path to regulatory approval is lengthy and capital-intensive, but the DRC's approval represents a tangible step forward for the company's clinical pipeline.

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