NanoViricides, Inc. (NYSE American: NNVC) announced that it has submitted an application to the Democratic Republic of Congo's regulatory agency for approval to initiate a Phase II clinical trial evaluating its NV-387 Oral Gummies as a treatment for the current Bundibugyo ebolavirus outbreak. The company has retained Om Sai Clinical Research Private Limited as the contract research organization for the study, with drug supplies already positioned in the DRC.
NV-387 is an orally administered broad-spectrum antiviral designed to target host-side mechanisms that viruses rely on to infect cells, which the company believes may reduce the likelihood of viral resistance. The planned study builds on NanoViricides' ongoing Phase II Mpox trial in the DRC and comes as the country grapples with an outbreak that, according to the release, has resulted in more than 930 deaths and nearly 2,400 confirmed cases since May.
The company said it believes NV-387's oral formulation could offer logistical advantages over infusion-based therapies in resource-limited settings. If successful, the trial could support the development of a broad-spectrum treatment for Ebola and other filoviruses. This is a significant step for NanoViricides, which is a clinical stage company creating special purpose nanomaterials for antiviral therapy. Its lead drug candidate, NV-387, is also being developed as a treatment for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox and Measles.
The application for the Ebola trial marks an expansion of NanoViricides' clinical pipeline. The company's other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. NV-CoV-2 (API NV-387) is the company's nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir, while NV-CoV-2-R encapsulates remdesivir within its polymeric micelles. The company believes that since remdesivir is already US FDA approved, its drug candidate encapsulating remdesivir is likely to be approvable if safety is comparable.
For leaders in business and technology, this development underscores the potential of novel antiviral platforms that can be rapidly deployed against emerging viral threats. The oral formulation of NV-387 could simplify logistics in outbreak settings, reducing the need for cold chain storage and trained medical personnel for intravenous administration. This could be a game-changer for pandemic preparedness in low-resource regions.
The company also holds a worldwide exclusive perpetual license to TheraCour nanomedicine technology for several drugs targeting HIV/AIDS, Hepatitis B and C, Rabies, Herpes, Influenza, Dengue, Japanese Encephalitis, West Nile, Ebola/Marburg, and certain Coronaviruses. The path to drug development is lengthy and requires substantial capital, and there can be no assurance that any of the company's candidates will show sufficient effectiveness and safety for human clinical development.
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