NanoViricides Receives Ethics Approval for Phase II Ebola Trial in DRC, Potentially Offering First Oral Treatment

NanoViricides, Inc. (NYSE American: NNVC) has received National Ethics Committee approval in the Democratic Republic of the Congo (DRC) for a Phase II clinical trial evaluating its NV-387 oral gummies as a treatment for the current Bundibugyo ebolavirus outbreak, the company announced. The approval marks a significant step forward for the clinical-stage company, which is also preparing to submit a Clinical Trial Application to the DRC regulatory agency, ACOREP. Notably, NV-387 drug product is already in the country for an upcoming Phase II Mpox trial, enabling rapid trial initiation if regulatory approval is received.

According to NanoViricides, NV-387 is the only orally administered Ebola treatment currently under consideration for clinical evaluation, offering potential advantages over infusion-based therapies in resource-limited outbreak settings. The company believes its broad-spectrum antiviral platform, designed to target host-cell features used by viruses, could provide a treatment option for Bundibugyo and other ebolaviruses that currently have no approved therapies or vaccines. This is particularly critical as the Bundibugyo ebolavirus has no specific approved treatments or vaccines, unlike the more common Zaire ebolavirus.

The company’s lead drug candidate, NV-387, is a broad-spectrum antiviral drug being developed for a range of viral infections, including RSV, COVID-19, Long COVID, Influenza, Mpox, and Measles. The Phase II trial in the DRC will evaluate the safety and efficacy of NV-387 in patients infected with Bundibugyo ebolavirus. If successful, it could address a significant unmet medical need in regions where intravenous treatments are often impractical due to lack of infrastructure.

NanoViricides’ platform technology, based on the TheraCour nanomedicine technology, aims to create special purpose nanomaterials for antiviral therapy. The company holds exclusive licenses for several drugs targeting a wide range of viral diseases, including HIV, Hepatitis B and C, Rabies, Herpes, Influenza, Dengue, and Ebola/Marburg viruses. The recent ethics approval in the DRC underscores the company’s commitment to advancing its pipeline into human clinical trials.

The successful initiation of this trial could also pave the way for broader applications of NV-387 against other viral threats. For more details, the full press release is available at https://ibn.fm/MuxOe. Investors can find the latest news and updates regarding NNVC at https://ibn.fm/NNVC.