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 decision marks a significant step forward for the only orally administered Ebola treatment candidate currently under consideration for clinical testing, according to the company.
NV-387 is a broad-spectrum antiviral designed to target host-cell features required by viruses, offering a potential advantage over traditional intravenous treatments that can be difficult to deploy and scale in resource-limited outbreak settings. 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.
“We are pleased to receive approval from the DRC Pillar Committee to advance our proposed Phase II Ebola trial,” said a NanoViricides spokesperson. “This approval underscores the potential of NV-387 as a critical tool in combating viral outbreaks, particularly in regions where healthcare infrastructure is challenged.”
The next steps include obtaining approvals from the DRC National Ethics Committee and regulatory agency ACOREP before initiating the study. NanoViricides believes that the oral formulation could offer significant advantages in outbreak settings, where intravenous treatments are often impractical.
NanoViricides’ lead drug candidate, NV-387, is also being developed for other viral infections, including RSV, COVID-19, influenza, mpox, and measles. The company’s platform technology is based on TheraCour® nanomedicine technology, licensed from TheraCour Pharma, Inc. For more information, visit the company’s newsroom at https://nnw.fm/NNVC.
The press release detailing the approval is available at https://nnw.fm/1ewVT. As with any drug development efforts, there can be no assurance that NV-387 will demonstrate sufficient effectiveness and safety for human clinical development.
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