NanoViricides, Inc. (NYSE American: NNVC) announced it 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 is preparing to submit a Clinical Trial Application to the DRC regulatory agency, ACOREP, and noted that 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.
The approval marks a significant step in addressing the Bundibugyo ebolavirus, which currently has no approved therapies or vaccines. NanoViricides stated that NV-387 is the only orally administered Ebola treatment 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 multiple ebolaviruses.
According to the press release, NanoViricides’ lead drug candidate NV-387 is a broad-spectrum antiviral being developed for respiratory viral infections, Mpox, and other diseases. The company’s nanoviricide technology aims to create special purpose nanomaterials for antiviral therapy. The clinical trial in the DRC will evaluate the safety and efficacy of NV-387 in patients infected with Bundibugyo ebolavirus.
The importance of this announcement lies in the urgent need for effective treatments against emerging viral threats. The Bundibugyo ebolavirus outbreak in the DRC underscores the necessity for readily deployable oral therapies that can be administered without cold chain logistics or intravenous access. If successful, NV-387 could become a critical tool in outbreak response, potentially reducing mortality and transmission rates.
NanoViricides’ platform technology is based on intellectual property licensed from TheraCour Pharma, Inc. The company holds exclusive licenses for several viral diseases, including Ebola. The ability to rapidly repurpose NV-387 for different viral indications demonstrates the platform’s versatility. The company noted that the drug product is already in the DRC for an Mpox trial, which could expedite the Ebola trial initiation.
For more details, view the full press release at https://ibn.fm/MuxOe. The latest news and updates regarding NNVC are available at https://ibn.fm/NNVC.
NanoViricides is a clinical-stage company focused on developing antiviral therapies using its nanoviricide technology. The company’s lead candidate NV-387 is being investigated for multiple viral infections, including COVID-19, influenza, and Mpox. The Phase II Ebola trial in the DRC represents a critical step in advancing the company’s pipeline and addressing global health needs.
