NanoViricides, Inc. (NYSE American: NNVC) announced it is awaiting regulatory approval to begin a Phase II clinical trial of its NV-387 Oral Gummies for the treatment of Bundibugyo ebolavirus in the Democratic Republic of the Congo after submitting an application to the local regulatory agency. The company said it has secured financing to support the study, which is designed to evaluate the oral antiviral in response to the ongoing Ebola outbreak, where no approved treatment or vaccine currently exists for the Bundibugyo strain.
NanoViricides said NV-387 is the only orally administered Ebola treatment candidate currently under consideration for clinical testing to its knowledge and believes its broad-spectrum antiviral mechanism could offer advantages over infusion-based therapies in resource-limited outbreak settings. The company noted sufficient quantities of the drug are already in the DRC to support the planned Ebola study, pending regulatory approval.
The full press release can be viewed at https://ibn.fm/t1kLC. According to the company, NV-387 is a broad-spectrum antiviral drug that they plan to develop as a treatment for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections, and even Measles. NanoViricides is a clinical stage company that creates special purpose nanomaterials for antiviral therapy, based on intellectual property and technology from TheraCour Pharma, Inc.
The company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. Their business model is based on licensing technology for specific application verticals of specific viruses. The lead drug candidate NV-387 is a 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, their drug candidate encapsulating remdesivir is likely to be an approvable drug if safety is comparable.
NanoViricides is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. The company's platform technology is based on the TheraCour nanomedicine technology, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms for the treatment of various human viral diseases.
As with any drug development efforts, there can be no assurance that any of the company's pharmaceutical candidates will show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance that successful results against coronavirus in the lab will lead to successful clinical trials or a successful pharmaceutical product.
